Primary Immunodeficiency Diseases (PID)
Conditions
Brief summary
The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.
Interventions
Intravenous administration in Study Part 1, subcutaneous administration in Study Parts 2 and 3
Sponsors
Baxalta now part of Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration * Diagnosis of a PID disorder as defined by World Health Organization criteria (IUIS Scientific Committee, Primary immunodeficiency diseases. Report of an IUIS Scientific Committee. Clin Exp Immunol. 1999) for which the subject has been receiving a regular regimen of IV immunoglobulin infusions every 21 ± 3 days or 28 ± 3 days or a regular SC immunoglobulin treatment at 1 to 2 week intervals over a period of at least 3 months pre-study at a dose of 300-800 mg/kg BW/4 weeks * Subjects are aged 2 years or older * Subjects have a serum trough level of IgG \> 4.5 g/L at the last documented determination * A negative serum pregnancy test for any female subject who is of childbearing potential * Female subjects of childbearing potential agree to practice birth control measures for the duration of the study
Exclusion criteria
* Subjects positive at enrollment for one or more of the following: Hepatitis B surface antigen (HBsAg), PCR for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1 * Subjects with levels of alanine amino transferase (ALT) or aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory * Subjects with neutropenia (defined as an absolute neutrophil count \[ANC\] \<= 500/mm3) * Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender * Subjects with a malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident) * Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease) * Subjects with anemia that would preclude phlebotomy for laboratory studies * Subjects who received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to study enrollment * Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin and/or ISG infusions * Subjects with IgA deficiency and known anti IgA antibodies * Subjects receiving antibiotic therapy for the treatment of infection within 7 days prior to enrollment * Subjects participating in another clinical study involving an investigational product or device within 28 days prior to study enrollment * Subjects with bleeding disorders or who are on anti-coagulation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage | Week 12 (IV) and week 32 or 33 (SC) | Expressed as (AUC\_SC/AUC\_IV) \* 100 |
| Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation | Administration of IGIV, 10%: - Part 1 = IV administration (IV) - Parts 2, 3a, 3b = SC administration (SC) |
| Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Throughout study (1 year and 9 months) | Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs |
| Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Throughout study (1 year and 9 months) | Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs |
| Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Throughout study (1 year and 9 months) | Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs |
| Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Throughout study (1 year and 9 months) | Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs |
| Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Throughout study (1 year and 9 months) | Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs |
| Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Throughout study (1 year and 9 months) | Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Part 3B: Maximum Plasma Concentration (C-max) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | Maximal immune globulin concentration after infusion |
| Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | Time to reach C-max |
| Study Part 3B: Minimum Plasma Concentration (C-min) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | Minimal immune globulin concentration after infusion |
| Study Part 3B: Area Under the Curve (AUC) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Study Parts 1, 2 and 3b, AUC(0-τ) was standardized for the infusion intervals (3 or 4 weeks vs. 1 week). |
| Study Part 3B: Weight-adjusted Clearance | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | Computed as weight-adjusted dose divided by total AUC |
| Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation | Part 1: IgG trough levels measured at each IV infusion day (every 3rd or 4th week depending on schedule/frequency of participants for a total of 12 weeks) Part 2: IgG trough levels measured at weeks 1, 5 and 9 (of a total of 12 weeks) Part 3a: IgG trough levels measured at weeks 1 and 5 (of a total of 6 weeks) Part 3b: IgG trough levels measured at weeks 1, 5, 9 and 12 (of a total of 12 weeks) |
| Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation | Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. |
| Trough Levels of Antibody to Hepatitis B in All Study Participants | Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation | Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. |
| Trough Levels of Antibody to Tetanus In All Study Participants | Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation | Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. |
| Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level | Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation | Antibody Titers That Were Below or Above the Protective Titer Level of \>1:8 for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. Participants had multiple anti-measles antibody titers measured during the study. |
| Annual Infection Rates During Treatment | Throughout the study, 1 year and 9 months | Annual rate of all infections calculated using a Poisson model to account for different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with allowance for overdispersion by deviance method. Point estimates and likelihood-ratio based 95% confidence intervals were provided. Infections as included in analysis comprised all reported AEs that were coded to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations, described as an infection by investigator, or for which anti-infective medication was prescribed. |
| Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS) | Throughout the study, 1 year and 9 months | Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with an allowance for overdispersion by the deviance method. |
| Rate of Temporally Associated AEs Per Infusion | During Infusion or Within 72 Hours of Completion of Infusions | Rate of AEs per infusion defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion (temporally associated) divided by the total number of infusions. |
| AEs Deemed/Judged to be Related by the Investigator | Throughout the study period (1 year and 9 months) | Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug that occur at any time during the study divided by the total number of infusions. |
| Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Throughout the study period (1 year and 9 months) | Frequency of Dose Adjustments Based on IgG Trough Levels \<4.5 g/L IgG, if Any, for Each Study Part. Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set. |
| Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | During Infusion or Within 72 Hours of Completion of Infusions | Proportion of Participants Reporting 1 or More Moderate or Severe AEs That Begin During Infusion or Within 72 Hours of Completion of an Infusion. |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Throughout entire study (1 year and 9 months) | Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Throughout entire study (1 year and 9 months) | Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions. |
| Study Part 1 (IV): Maximum Plasma Concentration (C-max) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion. | Maximal immune globulin concentration after infusion |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Throughout entire study (1 year and 9 months) | Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions. |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Throughout entire study (1 year and 9 months) | Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Throughout entire study (1 year and 9 months) | Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions. |
| Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Throughout the study period (1 year and 9 months) | — |
| Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | During Infusion or Within 72 Hours of Completion of Infusions | — |
| Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | During Infusion or Within 72 Hours of Completion of Infusions | — |
| Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | During Infusion or Within 72 Hours of Completion of Infusions | — |
| Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | During Infusion or Within 72 Hours of Completion of Infusions | — |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Throughout entire study (1 year and 9 months) | Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR |
| Study Part 1 (IV): Minimum Plasma Concentration (C-min) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion. | Minimal immune globulin concentration after infusion |
| Study Part 1 (IV): Weight-adjusted Clearance | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion. | Computed as weight-adjusted dose divided by total AUC |
| Study Part 1 (IV): Terminal Half-life | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion. | Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50%during the terminal phase. |
| Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | Maximal immune globulin concentration after infusion |
| Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | Time to reach C-max |
| Study Part 2 (SC): Minimum Plasma Concentration (C-min) | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | Minimal immune globulin concentration after infusion |
| Study Part 2 (SC): Weight-adjusted Clearance | Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion. | Computed as weight-adjusted dose divided by total AUC |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted in the United States at 9 study sites.
Pre-assignment details
53 participants who enrolled were screened. Of these, 4 withdrew before treatment (1 death, 1 screen failure, 2 requested withdrawal)
Participants by arm
| Arm | Count |
|---|---|
| Treated Participants | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part 1 - IV Infusions of IGIV, PK | Withdrawal by Subject | 1 | 0 |
| Part 2 - Subcutaneous (SC) IGIV, PK | Family Emergency | 0 | 1 |
| Part 2 - Subcutaneous (SC) IGIV, PK | Withdrawal by Subject | 1 | 2 |
| Study Extension Period | Protocol Violation | 1 | 0 |
| Study Extension Period | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Treated Participants |
|---|---|
| Age, Customized ≥ 12 years | 35 Participants |
| Age, Customized 2 to <12 years | 14 Participants |
| Region of Enrollment United States | 49 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 38 / 49 | 44 / 47 |
| serious Total, serious adverse events | 2 / 49 | 2 / 48 |
Outcome results
Primary
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years.
Administration of IGIV, 10%: - Part 1 = IV administration (IV) - Parts 2, 3a, 3b = SC administration (SC)
Time frame: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation
Population: Full safety data set (all participants, aged 2 to \<12 years who received any study drug)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 4 week Interval, Visit 1 (n=7) | 9.640 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 4 week Interval, Visit 2 (n=9) | 10.000 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 4 week Interval, Visit 3 (n=7) | 9.080 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 4 week Interval, Visit 4 (n=8) | 10.500 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 2 (SC), Visit 1 (n=12) | 13.650 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 2 (SC), Visit 5 (n=12) | 12.800 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 2 (SC), Visit 9 (n=12) | 13.600 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 3a (SC), Visit 5 (n=11) | 12.200 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 3b (SC), Visit 1 (n=12) | 11.500 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 3b (SC), Visit 5 (n=12) | 12.600 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 3b (SC), Visit 9 (n=12) | 12.800 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | End of Study (n=13) | 12.300 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), Screening visit (n=14) | 11.400 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 3 week Interval, Visit 1 (n=5) | 10.100 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 3 week Interval, Visit 2 (n=4) | 11.500 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 3 week Interval, Visit 3 (n=5) | 10.600 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 3 week Interval, Visit 4 (n=5) | 10.100 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 1 (IV), 3 week Interval, Visit 5 (n=5) | 10.800 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. | Part 3a (SC), Visit 1 (n=11) | 11.200 g/L |
Primary
Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Time frame: Throughout study (1 year and 9 months)
Population: Full safety data set (all participants who received any study drug)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 207 Infusions) | 6.7 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 595 Infusions) | 4.2 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=268 Infusions) | 3.1 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=538 Infusions) | 1.1 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 893 Infusions) | 0.6 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Parts 2, 3A, 3B, & Extension (n= 2,294 Infusions) | 1.9 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 893 Infusions) | 0.0 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 207 Infusions) | 6.2 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=538 Infusions) | 0.2 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 595 Infusions) | 0.5 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Parts 2, 3A, 3B, & Extension (n= 2,294 Infusions) | 0.2 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=268 Infusions) | 0.4 Percentage of Infusions |
Primary
Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Time frame: Throughout study (1 year and 9 months)
Population: SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 45 Infusions) | 0.0 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 126 Infusions) | 3.3 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=62 Infusions) | 0.0 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=120 Infusions) | 0.0 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 229 Infusions) | 0.4 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Parts 2, 3A, 3B, & Extension (n= 537 Infusions) | 0.9 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 229 Infusions) | 0.0 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 45 Infusions) | 0.0 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=120 Infusions) | 0.0 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 126 Infusions) | 0.0 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Parts 2, 3A, 3B, & Extension (n= 537 Infusions) | 0.0 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=62 Infusions) | 0.0 Percentage of Infusions |
Primary
Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Time frame: Throughout study (1 year and 9 months)
Population: SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 162 Infusions) | 8.7 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 469 Infusions) | 4.5 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=206 Infusions) | 4.0 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=418 Infusions) | 1.5 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 664 Infusions) | 0.6 Percentage of Infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Parts 2, 3A, 3B, & Extension (n= 1,757 Infusions) | 2.2 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 664 Infusions) | 0.0 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 162 Infusions) | 8.0 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=418 Infusions) | 0.2 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 469 Infusions) | 0.6 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Parts 2, 3A, 3B, & Extension (n= 1,757 Infusions) | 0.3 Percentage of Infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=206 Infusions) | 0.5 Percentage of Infusions |
Primary
Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Time frame: Throughout study (1 year and 9 months)
Population: Full safety data set (all participants who received any study drug)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 49) | 18.4 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 47) | 29.8 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=44) | 15.9 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=44) | 13.6 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 36) | 13.9 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2, 3A, 3B, Study Extension (n= 47) | 40.4 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 36) | 0.0 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 49) | 16.3 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=44) | 2.3 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 47) | 4.3 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2, 3A, 3B, Study Extension (n= 47) | 4.3 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=44) | 2.3 Percentage of Participants |
Primary
Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped.
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Time frame: Throughout study (1 year and 9 months)
Population: SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 3B (SC) (n=34) | 17.6 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Extension (SC) (n= 27) | 14.8 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 2, 3A, 3B, Study Extension (n= 36) | 47.2 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 1 (IV) (n= 38) | 23.7 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 2 (SC) (n= 36) | 33.3 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 3A (SC) (n=34) | 20.6 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 2 (SC) (n= 36) | 5.6 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 3B (SC) (n=34) | 2.9 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 1 (IV) (n= 38) | 21.1 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Extension (SC) (n= 27) | 0.0 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 3A (SC) (n=34) | 2.9 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. | Study Part 2, 3A, 3B, Study Extension (n= 36) | 5.6 Percentage of Participants |
Primary
Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Time frame: Throughout study (1 year and 9 months)
Population: SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 11) | 0.0 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 11) | 18.2 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=10) | 0.00 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=10) | 0.00 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 9) | 11.1 Percentage of Participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2, 3A, 3B, Study Extension (n= 11) | 18.2 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Extension (SC) (n= 9) | 0.00 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 1 (IV) (n= 11) | 0.00 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3B (SC) (n=10) | 0.00 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2 (SC) (n= 11) | 0.00 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 2, 3A, 3B, Study Extension (n= 11) | 0.00 Percentage of Participants |
| Infusion Rate Change - For Tolerability/AE | Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped | Study Part 3A (SC) (n=10) | 0.00 Percentage of Participants |
Primary
Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage
Expressed as (AUC\_SC/AUC\_IV) \* 100
Time frame: Week 12 (IV) and week 32 or 33 (SC)
Population: Participants, ≥12 years, with PK data in terms of AUC\[0-τ\]/week following IV administration and SC administration of IGIV, 10% at an adjusted/individually adapted dose in Study Part 3b
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage | 95.2 percent |
Secondary
AEs Deemed/Judged to be Related by the Investigator
Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug that occur at any time during the study divided by the total number of infusions.
Time frame: Throughout the study period (1 year and 9 months)
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | AEs Deemed/Judged to be Related by the Investigator | Study Part 2 (SC) (N = 595, 469, 126) | 0.07 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | AEs Deemed/Judged to be Related by the Investigator | Study Extension (SC) (N = 893, 664, 229) | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | AEs Deemed/Judged to be Related by the Investigator | Study Part 3a (SC) (N = 268, 206, 62) | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | AEs Deemed/Judged to be Related by the Investigator | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | AEs Deemed/Judged to be Related by the Investigator | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | AEs Deemed/Judged to be Related by the Investigator | Study Part 3b (SC) (N = 538, 418, 120) | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | AEs Deemed/Judged to be Related by the Investigator | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | AEs Deemed/Judged to be Related by the Investigator | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 0.25 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | AEs Deemed/Judged to be Related by the Investigator | Study Part 2 (SC) (N = 595, 469, 126) | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | AEs Deemed/Judged to be Related by the Investigator | Study Part 3a (SC) (N = 268, 206, 62) | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | AEs Deemed/Judged to be Related by the Investigator | Study Part 3b (SC) (N = 538, 418, 120) | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | AEs Deemed/Judged to be Related by the Investigator | Study Extension (SC) (N = 893, 664, 229) | 0.03 AEs per infusion |
| SESC | AEs Deemed/Judged to be Related by the Investigator | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 0.00 AEs per infusion |
| SESC | AEs Deemed/Judged to be Related by the Investigator | Study Extension (SC) (N = 893, 664, 229) | 0.00 AEs per infusion |
| SESC | AEs Deemed/Judged to be Related by the Investigator | Study Part 3b (SC) (N = 538, 418, 120) | 0.00 AEs per infusion |
| SESC | AEs Deemed/Judged to be Related by the Investigator | Study Part 2 (SC) (N = 595, 469, 126) | 0.08 AEs per infusion |
| SESC | AEs Deemed/Judged to be Related by the Investigator | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.00 AEs per infusion |
| SESC | AEs Deemed/Judged to be Related by the Investigator | Study Part 3a (SC) (N = 268, 206, 62) | 0.00 AEs per infusion |
Secondary
Annual Infection Rates During Treatment
Annual rate of all infections calculated using a Poisson model to account for different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with allowance for overdispersion by deviance method. Point estimates and likelihood-ratio based 95% confidence intervals were provided. Infections as included in analysis comprised all reported AEs that were coded to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations, described as an infection by investigator, or for which anti-infective medication was prescribed.
Time frame: Throughout the study, 1 year and 9 months
Population: Full safety data set (all participants who received any study drug)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Annual Infection Rates During Treatment | Study Part 3B (SC) | 3.9 Estimated infections per year |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Annual Infection Rates During Treatment | Study Part 2 (SC) | 5.6 Estimated infections per year |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Annual Infection Rates During Treatment | Study Extension (SC) | 4.0 Estimated infections per year |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Annual Infection Rates During Treatment | Study Part 3A (SC) | 3.5 Estimated infections per year |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Annual Infection Rates During Treatment | Study Part 2, 3A, 3B, Study Extension (all SC) | 4.3 Estimated infections per year |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Annual Infection Rates During Treatment | Study Part 1 (IV) | 5.0 Estimated infections per year |
| Infusion Rate Change - For Tolerability/AE | Annual Infection Rates During Treatment | Study Part 2, 3A, 3B, Study Extension (all SC) | 4.0 Estimated infections per year |
| Infusion Rate Change - For Tolerability/AE | Annual Infection Rates During Treatment | Study Part 1 (IV) | 5.2 Estimated infections per year |
| Infusion Rate Change - For Tolerability/AE | Annual Infection Rates During Treatment | Study Part 3A (SC) | 4.6 Estimated infections per year |
| Infusion Rate Change - For Tolerability/AE | Annual Infection Rates During Treatment | Study Part 3B (SC) | 3.8 Estimated infections per year |
| Infusion Rate Change - For Tolerability/AE | Annual Infection Rates During Treatment | Study Extension (SC) | 3.8 Estimated infections per year |
| Infusion Rate Change - For Tolerability/AE | Annual Infection Rates During Treatment | Study Part 2 (SC) | 4.1 Estimated infections per year |
Secondary
Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS)
Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with an allowance for overdispersion by the deviance method.
Time frame: Throughout the study, 1 year and 9 months
Population: Full Safety Data Set (All study participants who received any infusions)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS) | 0.000 Estimated infections/year |
| Infusion Rate Change - For Tolerability/AE | Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS) | 0.067 Estimated infections/year |
Secondary
Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L)
Frequency of Dose Adjustments Based on IgG Trough Levels \<4.5 g/L IgG, if Any, for Each Study Part. Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.
Time frame: Throughout the study period (1 year and 9 months)
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 1 (IV) | 0.00 ratio |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 2 (SC) | 0.00 ratio |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 3a (SC) | 0.00 ratio |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 3b (SC) | 0.00 ratio |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Extension (SC) | 0.00 ratio |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.00 ratio |
| Infusion Rate Change - For Tolerability/AE | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Extension (SC) | 0.00 ratio |
| Infusion Rate Change - For Tolerability/AE | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 3b (SC) | 0.00 ratio |
| Infusion Rate Change - For Tolerability/AE | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.00 ratio |
| Infusion Rate Change - For Tolerability/AE | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 3a (SC) | 0.00 ratio |
| Infusion Rate Change - For Tolerability/AE | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 1 (IV) | 0.00 ratio |
| Infusion Rate Change - For Tolerability/AE | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 2 (SC) | 0.00 ratio |
| SESC | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 3a (SC) | 0.00 ratio |
| SESC | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 2 (SC) | 0.00 ratio |
| SESC | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Extension (SC) | 0.00 ratio |
| SESC | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.00 ratio |
| SESC | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 1 (IV) | 0.00 ratio |
| SESC | Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) | Study Part 3b (SC) | 0.00 ratio |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)
Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR
Time frame: Throughout entire study (1 year and 9 months)
Population: All study participants who received any study drug during each of the study parts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 4 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 19 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 4 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 7 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 6 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 8 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 8 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 8 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 5 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 4 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 4 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 5 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 7 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 5 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 9 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 6 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 5 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 6 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 3 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 3 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 3 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 3 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 3 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 5 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 3 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 6 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 4 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 7 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 8 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 5 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 10 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 8 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 8 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 6 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 5 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 20 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 18 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 13 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 8 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 12 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 17 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 11 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 9 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 20 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 14 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 8 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 1 Adverse events |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)
Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR
Time frame: Throughout entire study (1 year and 9 months)
Population: All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 7 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 2 Adverse events |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages)
Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR
Time frame: Throughout entire study (1 year and 9 months)
Population: Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthritis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Moderate | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bursitis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Candidiasis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Confusional State-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Moderate | 6 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Mild | 7 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritability-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lethargy-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, R, Mild | 4 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dental Caries-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Mild | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paronychia-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Laceration-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Procedural Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hypoxia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Mild | 5 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hordeolum-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Macular-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Papular-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Moderate | 8 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Mild | 19 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Moderate | 4 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Goitre-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sunburn-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Furuncle-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Flank Pain-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fall-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Livedo Reticularis-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Excoriation-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Moderate | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myopia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Mild | 8 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Wheezing-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anorexia-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acne-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Alopecia-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Animal Bite-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Mild | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Moderate | 6 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diverticulitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Warm-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Toothache-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tendonitis-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Drug Eruption-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Severe | 3 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Device Failure-non-SAE, NR, Mild | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Mild | 4 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Breast Tenderness-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Severe | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blepharitis-non-SAE,NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Mild | 7 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haematochezia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, R, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, R, Severe | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | ADHD-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Head Injury-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthenia-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scoliosis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anxiety-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Mild | 0 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Moderate | 2 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, R, Mild | 1 Adverse events |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Externa-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Severe | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gravitational Oedema-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haematochezia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Head Injury-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scoliosis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Moderate | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Inguinal Mass-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acne-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Externa-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anxiety-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthropod Bite-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthenia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | ADHD-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Moderate | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, R, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Moderate | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Mild | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Furuncle-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Mild | 8 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Toothache-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dental Caries-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 5 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 3 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Procedural Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ammonia Increased-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hypoxia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Wheezing-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fall-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hordeolum-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Erythematous-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Papular-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Mild | 4 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, NR, Moderate | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Excoriation-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Moderate | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthritis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Disorder-non-SAE, NR, Severe | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anorexia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritability-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lethargy-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oral Herpes-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myopia-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 2 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 1 Adverse events |
| Infusion Rate Change - For Tolerability/AE | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Furuncle-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Toothache-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fungal Infection-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lethargy-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myopia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritability-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 3 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Procedural Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hypoxia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fall-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Wheezing-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hordeolum-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Lesion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Mild | 3 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Papular-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Excoriation-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Severe | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anorexia-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Moderate | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anxiety-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dental Caries-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scoliosis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthenia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haematochezia-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Externa-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 3 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Moderate | 4 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthritis-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, R, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Mild | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | ADHD-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Mild | 2 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acne-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, R, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Head Injury-non-SAE, NR, Mild | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Moderate | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, R, Severe | 0 Adverse events |
| SESC | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anorexia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Externa-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anxiety-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scoliosis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthenia-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | ADHD-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Head Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dental Caries-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haematochezia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Moderate | 3 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Pruritic-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Mild | 3 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, R, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Moderate | 4 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myopia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Moderate | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, R, Mild | 3 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oedema Peripheral-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oral Herpes-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Procedural Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Papular-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Toothache-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 5 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Wheezing-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acne-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Severe | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-SAE, NR, Severe | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Excoriation-non-SAE, NR, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fall-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Furuncle-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hordeolum-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hypoxia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Mild | 2 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritability-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lethargy-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Limb Injury-non-SAE, NR, Mild | 1 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, R, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Part 3b, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lethargy-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acne-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myopia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Limb Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Excoriation-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lip Ulceration-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 7 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Toothache-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Furuncle-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Mild | 5 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Lesion-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Mild | 8 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Papular-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Erythematous-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Mild | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hordeolum-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Mild | 9 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Procedural Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hypoxia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oral Herpes-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritability-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, R, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paraesthesia-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Externa-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scoliosis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Mild | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Severe | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Mild | 4 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Wheezing-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anorexia-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anxiety-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthropod Bite-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthenia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | ADHD-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dental Caries-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Moderate | 3 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fall-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haematochezia-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemorrhoids-non-SAE, NR, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Head Injury-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Mild | 8 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Moderate | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 5 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, R, Mild | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 1 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Mild | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 2 Adverse events |
| Study Extension, SC Administration | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Device Failure-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dermatitis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dental Caries-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cough-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Pruritic-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Mild | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Influenza-non-SAE, NR, Moderate | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Externa-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 11 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blepharitis-non-SAE,NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Back Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | ADHD-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthenia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lung Infection-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthropod Bite-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthritis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anxiety-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Anorexia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Wheezing-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Mild | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Varicose Vein-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urticaria-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paraesthesia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tendonitis-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Inguinal Mass-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sunburn-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Warm-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Moderate | 15 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oedema Peripheral-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Headache-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scoliosis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Scleritis-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemorrhoids-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Haematochezia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Head Injury-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gravitational Oedema-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Mild | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fall-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eczema-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Pain-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Laryngitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Procedural Pain-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hypoxia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Mild | 13 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pneumonia-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, R, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Animal Bite-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Moderate | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lethargy-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ammonia Increased-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Alopecia-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Constipation-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Insomnia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Acne-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myopia-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Diarrhoea-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Dyspnoea-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infection-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 8 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Ear Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vomiting-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pharyngitis-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Epistaxis-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Viral Infection-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Excoriation-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Paronychia-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Limb Injury-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 18 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Contusion-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Severe | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fatigue-non-SAE, R, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chest Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Lip Ulceration-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Flank Pain-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Toothache-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Fungal Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chills-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Myalgia-non-SAE, NR, Mild | 8 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Candidiasis-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Furuncle-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Lesion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Irritability-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Skin Laceration-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pain-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bursitis-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinusitis-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Otitis Media-non-SAE, NR, Moderate | 7 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Disorder-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Disorder-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Goitre-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Mild | 16 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Sinus Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Convulsion-non-SAE, NR, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Confusional State-non-SAE, R, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Moderate | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Oral Herpes-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasal Congestion-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, NR, Severe | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rhinitis-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, R, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Papular-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Headache-non-SAE, R, Mild | 15 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Bronchitis-non-SAE, NR, Mild | 5 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Macular-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash Erythematous-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Asthma-non-SAE, NR, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Mild | 9 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, R, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Arthralgia-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Rash-non-SAE, NR, Mild | 0 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Croup Infectious-non-SAE, NR, Mild | 3 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Migraine-non-SAE, R, Severe | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, R, Mild | 6 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nausea-non-SAE, NR, Mild | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Malaise-non-SAE, R, Moderate | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Hordeolum-non-SAE, NR, Mild | 1 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Moderate | 2 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 4 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Pyrexia-non-SAE, NR, Mild | 11 Adverse events |
| Total SC (Parts 2, 3a, 3b, Extension) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 2 Adverse events |
Secondary
Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level
Antibody Titers That Were Below or Above the Protective Titer Level of \>1:8 for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. Participants had multiple anti-measles antibody titers measured during the study.
Time frame: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation
Population: All study participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level | Anti-Measles Antibody Tests Below a Titer of >1:8 | 0 Antibody titers |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level | Anti-Measles Antibody Tests Above a Titer of >1:8 | 654 Antibody titers |
Secondary
Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.
Time frame: During Infusion or Within 72 Hours of Completion of Infusions
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 28.5 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 11.8 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 10.1 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 7.2 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 7.3 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 8.8 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 9.3 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 32.7 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 7.2 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 8.1 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 12.2 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 11.2 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 10.3 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 6.5 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 6.9 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 7.5 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 13.3 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 4.8 Percentage of infusions |
Secondary
Percentage of Infusions Associated With ≥1 AE Related to the Study Drug
Time frame: Throughout the study period (1 year and 9 months)
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 22.2 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 2 (SC) (N = 595, 469, 126) | 9.9 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 3a (SC) (N = 268, 206, 62) | 7.8 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 3b (SC) (N = 538, 418, 120) | 3.5 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Extension (SC) (N = 893, 664, 229) | 3.1 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Total SC (N = 2294, 1757, 537) | 5.5 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Total SC (N = 2294, 1757, 537) | 6.1 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 27.8 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 3b (SC) (N = 538, 418, 120) | 4.3 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Extension (SC) (N = 893, 664, 229) | 3.8 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 2 (SC) (N = 595, 469, 126) | 10.2 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 3a (SC) (N = 268, 206, 62) | 8.3 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 2 (SC) (N = 595, 469, 126) | 8.7 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 3a (SC) (N = 268, 206, 62) | 6.5 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Total SC (N = 2294, 1757, 537) | 3.5 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 3b (SC) (N = 538, 418, 120) | 0.8 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 2.2 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AE Related to the Study Drug | Study Extension (SC) (N = 893, 664, 229) | 1.3 Percentage of infusions |
Secondary
Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion
Time frame: During Infusion or Within 72 Hours of Completion of Infusions
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 30.9 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 2 (SC) (N = 595, 469, 126) | 15.0 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 3a (SC) (N = 268, 206, 62) | 11.6 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 3b (SC) (N = 538, 418, 120) | 8.7 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Extension (SC) (N = 893, 664, 229) | 9.4 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Total SC (N = 2294, 1757, 537) | 10.9 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Total SC (N = 2294, 1757, 537) | 11.8 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 35.8 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 3b (SC) (N = 538, 418, 120) | 8.9 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Extension (SC) (N = 893, 664, 229) | 10.5 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 2 (SC) (N = 595, 469, 126) | 15.8 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 3a (SC) (N = 268, 206, 62) | 12.6 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 2 (SC) (N = 595, 469, 126) | 11.9 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 3a (SC) (N = 268, 206, 62) | 8.1 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Total SC (N = 2294, 1757, 537) | 8.2 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 3b (SC) (N = 538, 418, 120) | 8.3 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 13.3 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion | Study Extension (SC) (N = 893, 664, 229) | 6.1 Percentage of infusions |
Secondary
Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.
Time frame: During Infusion or Within 72 Hours of Completion of Infusions
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 1.0 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 4.9 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 2.2 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 1.5 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 1.1 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 2.3 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 2.7 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 1.2 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 1.9 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 1.4 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 5.1 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 2.9 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 4.0 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 0.0 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 1.1 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 0.0 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 0.0 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 0.4 Percentage of infusions |
Secondary
Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.
Time frame: During Infusion or Within 72 Hours of Completion of Infusions
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 28.0 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 6.3 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 6.8 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 7.6 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 7.8 Percentage of infusions |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 6.1 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 8.3 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 5.7 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 32.1 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 7.7 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 6.9 Percentage of infusions |
| Infusion Rate Change - For Tolerability/AE | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 7.0 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Total SC (N = 2294, 1757, 537) | 6.0 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 13.3 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 2 (SC) (N = 595, 469, 126) | 7.1 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3a (SC) (N = 268, 206, 62) | 6.5 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Part 3b (SC) (N = 538, 418, 120) | 7.5 Percentage of infusions |
| SESC | Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. | Study Extension (SC) (N = 893, 664, 229) | 4.4 Percentage of infusions |
Secondary
Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs
Proportion of Participants Reporting 1 or More Moderate or Severe AEs That Begin During Infusion or Within 72 Hours of Completion of an Infusion.
Time frame: During Infusion or Within 72 Hours of Completion of Infusions
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 1 (IV) | 0.43 Proportion of participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 3b (SC) | 0.36 Proportion of participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 2 (SC) | 0.36 Proportion of participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 3a (SC) | 0.23 Proportion of participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Extension (SC) | 0.50 Proportion of participants |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.66 Proportion of participants |
| Infusion Rate Change - For Tolerability/AE | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.75 Proportion of participants |
| Infusion Rate Change - For Tolerability/AE | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 2 (SC) | 0.44 Proportion of participants |
| Infusion Rate Change - For Tolerability/AE | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Extension (SC) | 0.56 Proportion of participants |
| Infusion Rate Change - For Tolerability/AE | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 3a (SC) | 0.24 Proportion of participants |
| Infusion Rate Change - For Tolerability/AE | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 1 (IV) | 0.47 Proportion of participants |
| Infusion Rate Change - For Tolerability/AE | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 3b (SC) | 0.38 Proportion of participants |
| SESC | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Total SC (Study Parts 2, 3A, 3B, Study Extension) | 0.36 Proportion of participants |
| SESC | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 1 (IV) | 0.27 Proportion of participants |
| SESC | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Extension (SC) | 0.33 Proportion of participants |
| SESC | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 3b (SC) | 0.30 Proportion of participants |
| SESC | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 2 (SC) | 0.09 Proportion of participants |
| SESC | Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Study Part 3a (SC) | 0.20 Proportion of participants |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)
Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions.
Time frame: Throughout entire study (1 year and 9 months)
Population: All study participants who received any study drug during each of the study parts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 0.75 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0.75 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0.75 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0.23 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0.38 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.23 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 0.63 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 0.23 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0.38 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 0.75 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 0.46 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0.38 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 0.63 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 1.10 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 0.23 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.23 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 0.38 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 0.20 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0.13 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 0.15 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 0.16 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 0.14 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 0.16 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 0.15 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0.33 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.33 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0.14 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0.50 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 0.25 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 0.16 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 0.27 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0.18 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 0.13 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.14 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0.29 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 0.12 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0.13 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0.11 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 0.11 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0.09 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Dislocation-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemoglobin Decreased-non-SAE, R, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Severe | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haematochezia-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gravitational Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lip Ulceration-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sports Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, R, Moderate | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Memory Impairment-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Furuncle-non-SAE, NR, Moderate | 0.12 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fungal Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.33 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteopenia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fall-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscle Strain-non-SAE, NR, Mild | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Constipation-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Streptococcal Infection-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Polyps-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Exostosis-non-SAE, NR,Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hordeolum-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Moderate | 0.18 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tourette's Disorder-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hiatus Hernia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Hypoxia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Infection-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Disorder-non-SAE, NR, Severe | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Implant Site Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Moderate | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Erythema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Severe | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Infection Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Headache-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wheezing-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, R, Mild | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinus Congestion-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Externa-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Decreased-non-SAE, R, Mild | 0.50 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Irritation-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Severe | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Mild | 0.16 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Moderate | 0.24 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Contusion-non-SAE, R, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pain-non-SAE, R, Moderate | 0.16 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthropod Bite-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dental Caries-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, R, Mild | 0.14 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Costochondritis-non-SAE, NR, Severe | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Mild | 0.16 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Addison's Disease-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Severe | 0.12 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oedema Peripheral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Moderate | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Swelling-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acute Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis-non-SAE, NR, Moderate | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Pain-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Headache-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Varicose Vein-non-SAE, NR, Severe | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myalgia-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Head Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthenia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Haemorrhoids-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Severe | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, R, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vomiting-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Disorder-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Epistaxis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Excoriation-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, R, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Viral Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Irritation-non-SAE, R, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Eye Oedema-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vestibulitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Vaginal Lesion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Mild | 0.11 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.12 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasopharyngitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Blood Pressure Increased-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Urticaria-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Flatulence-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Toothache-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Back Pain-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastric Ulcer-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Tooth Fracture-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | ADHD-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Skin Lesion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Asthma-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Influenza-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Related Reaction-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthritis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Arthralgia-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.14 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scoliosis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anxiety-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Anorexia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nausea-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Insomnia-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ammonia Increased-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Reaction-non-SAE, R, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oral Herpes-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Vesicles-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Road Traffic Accident-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinorrhoea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Inguinal Mass-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Injection Site Haematoma-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Pruritic-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Papular-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Irritability-non-SAE, NR, Mild | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Sprain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Rash Erythematous-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Joint Swelling-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pyrexia-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Laryngitis Viral-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Procedural Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lethargy-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pneumonia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Limb Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pharyngitis-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Periorbital Oedema-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Lymphadenopathy-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Paraesthesia-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Heart Rate Increased-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Malaise-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, R, Mild | 0.21 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Moderate | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Moderate | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Migraine-non-SAE, R, Severe | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Distension-non-SAE, NR, Mild | 0.29 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Osteomyelitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Muscular Weakness-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Discomfort- non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Fatigue-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Acne-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Tenderness-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, R, Mild | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Myopia-non-SAE, NR, Mild | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Croup Infectious-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cystitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cough-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dermatitis Contact-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chronic Sinusitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Nasal Congestion-non-SAE, NR, Moderate | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Diarrhoea-non-SAE, R, Mild | 0.19 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Chest Pain-SAE, NR, Severe | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Abdominal Pain-non-SAE, NR, Mild | 0.11 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Cardiac Murmur-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspepsia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Dyspnoea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Ear Pain-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Wound-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Bronchitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) | Otitis Media-non-SAE, NR, Moderate | 0.14 AEs per infusion |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)
Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions.
Time frame: Throughout entire study (1 year and 9 months)
Population: All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.23 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0.16 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0.33 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0.29 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, R, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Lymphadenopathy-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Costochondritis-non-SAE, NR, Severe | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haematoma-non-SAE, R, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Pain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Sprain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Severe | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Flatulence-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Cystitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pharyngitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Moderate | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pain-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Conjunctivitis Infective-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pain In Extremity-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Distension-non-SAE, NR, Mild | 0.29 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, R, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Arthralgia-non-SAE, NR, Moderate | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dermatitis Contact-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Folliculitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Discomfort- non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Osteopenia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Wound-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Migraine-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Blepharitis-non-SAE,NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vomiting-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Joint Swelling-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Acne-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Diarrhoea-non-SAE, R, Mild | 0.33 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Viral Up. Respir Tract Infec-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Vestibulitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Abdominal Tenderness-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Chronic Sinusitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspepsia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Breath Sounds Abnormal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Pruritus-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oral Herpes-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Dyspnoea-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Pain-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Muscle Strain-non-SAE, NR, Mild | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Ear Pain-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Headache-non-SAE, R, Mild | 0.16 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sports Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Oedema Peripheral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Memory Impairment-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Back Pain-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Exostosis-non-SAE, NR,Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Sinusitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasal Congestion-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Infection Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infection-non-SAE, NR, Moderate | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Bronchitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Addison's Disease-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Irritation-non-SAE, R, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Laryngitis Viral-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Rales-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Asthenia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Influenza-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Eye Oedema-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nausea-non-SAE, NR, Mild | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pyrexia-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Infusion Site Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Injection Site Haematoma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Nasopharyngitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Fatigue-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) | Pneumonia Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages)
Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions.
Time frame: Throughout entire study (1 year and 9 months)
Population: Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Procedural Pain-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Toothache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, R, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Excoriation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Device Failure-non-SAE, NR, Mild | 0.23 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 0.38 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blepharitis-non-SAE,NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | ADHD-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acne-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Flank Pain-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anxiety-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Animal Bite-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Mild | 1.10 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritability-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Alopecia-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Moderate | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, R, Mild | 0.75 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fall-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hordeolum-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Severe | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haematochezia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0.38 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hypoxia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Severe | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Confusional State-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tendonitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Goitre-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Moderate | 0.38 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Severe | 0.38 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Moderate | 0.63 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Furuncle-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Head Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Severe | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Infection-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.23 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Mild | 0.75 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Papular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Macular-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Mild | 0.63 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Externa-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paronychia-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dental Caries-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Moderate | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Mild | 0.75 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sunburn-non-SAE, NR, Severe | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Candidiasis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bursitis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, R, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthenia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anorexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scoliosis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myopia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Moderate | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Mild | 0.46 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Wheezing-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Severe | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Laceration-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lethargy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Lesion-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0.20 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Warm-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Mild | 0.50 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 0.25 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Externa-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scoliosis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Wheezing-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Head Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Mild | 0.13 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Furuncle-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Severe | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0.25 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Mild | 0.14 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritability-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lethargy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acne-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anorexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthenia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dental Caries-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Mild | 0.13 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hypoxia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, R, Moderate | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, R, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Procedural Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Toothache-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, R, Moderate | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myopia-non-SAE, NR, Mild | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 0.16 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fall-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | ADHD-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Mild | 0.17 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anxiety-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Mild | 0.23 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0.10 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Excoriation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Papular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oral Herpes-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hordeolum-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haematochezia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Excoriation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myopia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Toothache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Wheezing-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fall-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Severe | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0.50 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hordeolum-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haematochezia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hypoxia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Mild | 0.15 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritability-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthritis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.33 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Papular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, R, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Head Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | ADHD-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Moderate | 0.14 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthenia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anxiety-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anorexia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acne-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scoliosis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Procedural Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Mild | 0.25 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Externa-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dental Caries-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Furuncle-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lethargy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.17 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| SESC | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hypoxia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Moderate | 0.18 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Lesion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lethargy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Limb Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myopia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, R, Mild | 0.27 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scoliosis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acne-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anorexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anxiety-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthenia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Severe | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | ADHD-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-SAE, NR, Severe | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dental Caries-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Externa-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Moderate | 0.13 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Procedural Pain-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Wheezing-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Head Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Furuncle-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fall-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Excoriation-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Papular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 0.16 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haematochezia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Toothache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hordeolum-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Mild | 0.17 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oral Herpes-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritability-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Part 3b, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hordeolum-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oral Herpes-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Mild | 0.12 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Mild | 0.11 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Severe | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthritis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Mild | 0.11 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fall-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Excoriation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, R, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Severe | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dental Caries-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis-non-SAE, NR, Moderate | 0.09 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Toothache-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, R, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lethargy-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Furuncle-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haematochezia-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Limb Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Papular-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Wheezing-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Head Injury-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Externa-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scoliosis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Lesion-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acne-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myopia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Infection-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Severe | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anorexia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, R, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anxiety-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hypoxia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.14 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthenia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | ADHD-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Procedural Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritability-non-SAE, NR, Mild | 0.13 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0.00 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, R, Severe | 0.07 AEs per infusion |
| Study Extension, SC Administration | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urinary Tract Infection-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blood Pressure Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Fracture-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Mild | 0.12 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Limb Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Pruritic-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Related Reaction-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bursitis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lethargy-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis Fungal-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Candidiasis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cardiac Murmur-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cervical Spinal Stenosis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Laceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemoglobin Decreased-non-SAE, R, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Moderate | 0.24 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chest Pain-SAE, NR, Severe | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritability-non-SAE, NR, Mild | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haematochezia-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Warm-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Haemorrhoids-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Vesicles-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Croup Infectious-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cryptosporidiosis Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Joint Dislocation-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Moderate | 0.18 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Head Injury-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Externa-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Moderate | 0.14 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Otitis Media-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Lesion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Skin Infection-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paraesthesia-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Flank Pain-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Periorbital Oedema-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Inguinal Mass-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis Streptococcal-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Osteomyelitis-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tourette's Disorder-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Reaction-non-SAE, R, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Decreased-non-SAE, R, Mild | 0.50 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Upper Respir. Tract Infect-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fungal Infection-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Erythematous-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Implant Site Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Macular-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Furuncle-non-SAE, NR, Moderate | 0.12 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Congestion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haemorrhage-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinorrhoea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infect.-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Upper Respir. Tract Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Wheezing-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Skin Papilloma-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Mycotic Infection-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, R, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Discomfort- non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Disorder-non-SAE, NR, Severe | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dyspnoea-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scoliosis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, R, Mild | 0.27 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginal Lesion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vulvovaginal Candidiasis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Severe | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acne-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Infection-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Acute Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Animal Bite-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Road Traffic Accident-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hypoxia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anorexia-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nausea-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Haematoma-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Anxiety-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.14 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, NR, Moderate | 0.11 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthropod Bite-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Headache-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Disorder-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthenia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis Allergic-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Scleritis-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinus Congestion-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lymphadenopathy-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eczema-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | ADHD-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Erythema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthritis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Back Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, R, Severe | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sinusitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Intermit. Explosive Disorder-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect. Viral-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pneumonia Streptococcal-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vaginitis Bacterial-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oral Herpes-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Rash-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Cough-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma-non-SAE, NR, Severe | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respir. Tract Infect Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, R, Mild | 0.22 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dental Caries-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Urticaria-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Laryngitis-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Moderate | 0.13 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Mouth Ulceration-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Arthralgia-non-SAE, R, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lip Ulceration-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rhinitis-non-SAE, NR, Moderate | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, R, Moderate | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Dermatitis Contact-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Toothache-non-SAE, NR, Moderate | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hiatus Hernia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Oedema Peripheral-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, NR, Severe | 0.12 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Mucosal Disorder-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Device Failure-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ammonia Increased-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tendonitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Alopecia-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Congestion-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Sunburn-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Livedo Reticularis-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Mild | 0.18 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Suicidal Ideation-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hordeolum-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastric Ulcer-non-SAE, NR, Mild | 0.09 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Tooth Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pyrexia-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Streptococcal Infection-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, R, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Subcutaneous Abscess-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Hyperlipidaemia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Swelling-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Headache-non-SAE, R, Severe | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Muscular Weakness-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Moderate | 0.16 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Lung Infection-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myopia-non-SAE, NR, Mild | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chills-non-SAE, R, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Drug Eruption-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Centrl Venous Catheterisation-non-SAE, NR, Moderat | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pruritus-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Moderate | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | C.O.P.D.-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Ear Pain-non-SAE, R, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diverticulitis-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Bronchitis-non-SAE, NR, Moderate | 0.12 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Chronic Sinusitis-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Injection Site Haematoma-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Breast Tenderness-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash Papular-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Epistaxis-non-SAE, NR, Moderate | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasopharyngitis-non-SAE, NR, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Confusional State-non-SAE, R, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Infectious-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Pain-non-SAE, R, Mild | 0.16 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctival Hyperaemia-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pharyngitis-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, R, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Allergic-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea Haemorrhagic-non-SAE, NR,Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Mild | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Excoriation-non-SAE, NR, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Systolic Increased-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Procedural Pain-non-SAE, NR, Moderate | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Conjunctivitis Infective-non-SAE, NR, Mild | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Eye Infection Viral-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, R, Mild | 0.05 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | B.P. Diastolic Decreased-non-SAE, R, Mild | 0.33 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fall-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Irritable Bowel Syndrome-non-SAE, NR, Moderate | 0.06 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Migraine-non-SAE, NR, Severe | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Blepharitis-non-SAE,NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Respiratory Rate Increased-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Pain In Extremity-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Infusion Site Irritation-non-SAE, R, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Constipation-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Diarrhoea-non-SAE, NR, Moderate | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Influenza-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Abdominal Pain Upper-non-SAE, R, Mild | 0.10 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Biliary Tract Infection Bacterial-SAE, NR, Moderat | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Heart Rate Increased-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, NR, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Rash-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Vomiting-non-SAE, NR, Mild | 0.07 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Nasal Polyps-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Mild | 0.11 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Insomnia-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Contusion-non-SAE, R, Mild | 0.17 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Malaise-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Viral Infection-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Goitre-non-SAE, NR, Mild | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Asthma Exercise Induced-non-SAE, NR, Moderate | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Gravitational Oedema-non-SAE, R, Mild | 0.08 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Convulsion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Varicose Vein-non-SAE, NR, Severe | 0.04 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Myalgia-non-SAE, NR, Mild | 0.9 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Middle Ear Effusion-non-SAE, NR, Moderate | 0.00 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Fatigue-non-SAE, NR, Moderate | 0.03 AEs per infusion |
| Total SC (Parts 2, 3a, 3b, Extension) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) | Paronychia-non-SAE, NR, Mild | 0.00 AEs per infusion |
Secondary
Rate of Temporally Associated AEs Per Infusion
Rate of AEs per infusion defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion (temporally associated) divided by the total number of infusions.
Time frame: During Infusion or Within 72 Hours of Completion of Infusions
Population: All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of Temporally Associated AEs Per Infusion | Study Part 3a (SC) (N = 268, 206, 62) | 0.00 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of Temporally Associated AEs Per Infusion | Total SC (N = 2294, 1757, 537) | 0.08 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of Temporally Associated AEs Per Infusion | Study Part 2 (SC) (N = 595, 469, 126) | 0.08 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of Temporally Associated AEs Per Infusion | Study Part 3b (SC) (N = 538, 418, 120) | 0.08 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of Temporally Associated AEs Per Infusion | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 0.25 AEs per infusion |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Rate of Temporally Associated AEs Per Infusion | Study Extension (SC) (N = 893, 664, 229) | 0.07 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of Temporally Associated AEs Per Infusion | Study Part 2 (SC) (N = 595, 469, 126) | 0.13 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of Temporally Associated AEs Per Infusion | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 0.45 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of Temporally Associated AEs Per Infusion | Study Part 3b (SC) (N = 538, 418, 120) | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of Temporally Associated AEs Per Infusion | Study Part 3a (SC) (N = 268, 206, 62) | 0.08 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of Temporally Associated AEs Per Infusion | Study Extension (SC) (N = 893, 664, 229) | 0.09 AEs per infusion |
| Infusion Rate Change - For Tolerability/AE | Rate of Temporally Associated AEs Per Infusion | Total SC (N = 2294, 1757, 537) | 0.08 AEs per infusion |
| SESC | Rate of Temporally Associated AEs Per Infusion | Total SC (N = 2294, 1757, 537) | 0.00 AEs per infusion |
| SESC | Rate of Temporally Associated AEs Per Infusion | Study Part 3a (SC) (N = 268, 206, 62) | 0.00 AEs per infusion |
| SESC | Rate of Temporally Associated AEs Per Infusion | Study Part 3b (SC) (N = 538, 418, 120) | 0.00 AEs per infusion |
| SESC | Rate of Temporally Associated AEs Per Infusion | Study Part 1 (IV) (Units Analyzed N= 207, 162, 45) | 0.00 AEs per infusion |
| SESC | Rate of Temporally Associated AEs Per Infusion | Study Part 2 (SC) (N = 595, 469, 126) | 0.08 AEs per infusion |
| SESC | Rate of Temporally Associated AEs Per Infusion | Study Extension (SC) (N = 893, 664, 229) | 0.00 AEs per infusion |
Secondary
Study Part 1 (IV): Maximum Plasma Concentration (C-max)
Maximal immune globulin concentration after infusion
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 1 (IV): Maximum Plasma Concentration (C-max) | 22.7 g/L |
Secondary
Study Part 1 (IV): Minimum Plasma Concentration (C-min)
Minimal immune globulin concentration after infusion
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 1 (IV): Minimum Plasma Concentration (C-min) | 10.1 g/L |
Secondary
Study Part 1 (IV): Terminal Half-life
Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50%during the terminal phase.
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 1 (IV): Terminal Half-life | 33.1 days |
Secondary
Study Part 1 (IV): Weight-adjusted Clearance
Computed as weight-adjusted dose divided by total AUC
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 1 (IV): Weight-adjusted Clearance | 1.36 mL/kg/day |
Secondary
Study Part 2 (SC): Minimum Plasma Concentration (C-min)
Minimal immune globulin concentration after infusion
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 2 (SC): Minimum Plasma Concentration (C-min) | 12.5 g/L |
Secondary
Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max)
Time to reach C-max
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max) | 4.8 days |
Secondary
Study Part 2 (SC): Weight-adjusted Clearance
Computed as weight-adjusted dose divided by total AUC
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 2 (SC): Weight-adjusted Clearance | 1.86 mL/kg/day |
Secondary
Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max)
Maximal immune globulin concentration after infusion
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max) | 14.5 g/L |
Secondary
Study Part 3B: Area Under the Curve (AUC)
The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Study Parts 1, 2 and 3b, AUC(0-τ) was standardized for the infusion intervals (3 or 4 weeks vs. 1 week).
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 3B: Area Under the Curve (AUC) | 94.6 g*days/L |
Secondary
Study Part 3B: Maximum Plasma Concentration (C-max)
Maximal immune globulin concentration after infusion
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 3B: Maximum Plasma Concentration (C-max) | 14.1 g/L |
Secondary
Study Part 3B: Minimum Plasma Concentration (C-min)
Minimal immune globulin concentration after infusion
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 3B: Minimum Plasma Concentration (C-min) | 12.6 g/L |
Secondary
Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max)
Time to reach C-max
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max) | 2.9 days |
Secondary
Study Part 3B: Weight-adjusted Clearance
Computed as weight-adjusted dose divided by total AUC
Time frame: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.
Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Study Part 3B: Weight-adjusted Clearance | 2.00 mL/kg/day |
Secondary
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants
Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.
Time frame: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation
Population: All participants with specific antibody test results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 3 week Interval, Visit 2 (n=10) | 2.885 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 3 week Interval, Visit 3 (n=10) | 3.150 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 3 week Interval, Visit 4 (n=10) | 3.145 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, Screening visit (n=49) | 2.790 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 3 week Interval, Visit 1 (n=10) | 2.830 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 3 week Interval, Visit 5 (n=10) | 3.045 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 4 week Interval, Visit 1 (n=38) | 2.210 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 4 week Interval, Visit 2 (n=39) | 2.030 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 4 week Interval, Visit 3 (n=39) | 2.130 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 1, 4 week Interval, Visit 4 (n=38) | 2.135 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 2, Visit 1 (n=47) | 3.280 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 2, Visit 5 (n=46) | 2.810 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 2, Visit 9 (n=44) | 3.175 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 3a, Visit 1 (n=44) | 2.840 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 3b, Visit 1 (n=43) | 3.030 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 3b, Visit 5 (n=41) | 3.070 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Part 3b, Visit 9 (n=44) | 3.285 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | Extension, Visit 1 (n=36) | 2.940 µg/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants | End of Study (n=46) | 3.010 µg/mL |
Secondary
Trough Levels of Antibody to Hepatitis B in All Study Participants
Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.
Time frame: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation
Population: All participants with specific antibody test results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | End of Study (n=44) | 319.600 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, Screening visit (n=36) | 239.450 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 3 week Interval, Visit 1 (n=8) | 182.050 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 3 week Interval, Visit 2 (n=10) | 251.150 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 3 week Interval, Visit 3 (n=10) | 282.050 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 3 week Interval, Visit 4 (n=10) | 274.200 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 3 week Interval, Visit 5 (n=10) | 261.850 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 4 week Interval, Visit 1 (n=36) | 197.750 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 4 week Interval, Visit 2 (n=39) | 213.600 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 4 week Interval, Visit 3 (n=39) | 202.800 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 1, 4 week Interval, Visit 4 (n=38) | 207.850 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 2, Visit 1 (n=46) | 401.350 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 2, Visit 5 (n=46) | 341.100 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 2, Visit 9 (n=44) | 316.800 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 3a, Visit 1 (n=44) | 318.450 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 3b, Visit 1 (n=43) | 385.200 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 3b, Visit 5 (n=41) | 314.100 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Part 3b, Visit 9 (n=44) | 351.050 mIU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Hepatitis B in All Study Participants | Extension, Visit 1 (n=36) | 328.750 mIU/mL |
Secondary
Trough Levels of Antibody to Tetanus In All Study Participants
Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.
Time frame: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation
Population: All participants with specific antibody test results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Extension, Visit 1 (n=36) | 3.355 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, Screening visit (n=49) | 2.840 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 3 week Interval, Visit 1 (n=10) | 3.010 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 3 week Interval, Visit 2 (n=10) | 3.500 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 3 week Interval, Visit 3 (n=10) | 3.360 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 3 week Interval, Visit 4 (n=10) | 3.205 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 3 week Interval, Visit 5 (n=10) | 3.520 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 4 week Interval, Visit 1 (n=37) | 2.340 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 4 week Interval, Visit 2 (n=39) | 2.360 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 4 week Interval, Visit 3 (n=38) | 2.125 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 1, 4 week Interval, Visit 4 (n=36) | 2.325 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 2, Visit 1 (n=47) | 4.310 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 2, Visit 5 (n=46) | 3.445 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 2, Visit 9 (n=43) | 3.720 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 3a, Visit 1 (n=44) | 3.090 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 3b, Visit 1 (n=43) | 3.690 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 3b, Visit 5 (n=41) | 3.410 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | Part 3b, Visit 9 (n=43) | 3.150 IU/mL |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of Antibody to Tetanus In All Study Participants | End of Study (n=46) | 3.860 IU/mL |
Secondary
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older
Part 1: IgG trough levels measured at each IV infusion day (every 3rd or 4th week depending on schedule/frequency of participants for a total of 12 weeks) Part 2: IgG trough levels measured at weeks 1, 5 and 9 (of a total of 12 weeks) Part 3a: IgG trough levels measured at weeks 1 and 5 (of a total of 6 weeks) Part 3b: IgG trough levels measured at weeks 1, 5, 9 and 12 (of a total of 12 weeks)
Time frame: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation
Population: Full safety data set (all participants who received any study drug), 12 Years and Older
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 3 week Interval, Visit 4 (n=5) | 11.700 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 4 week Interval, Visit 4 (n=30) | 10.150 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 3a, Visit 5 (n=31) | 13.100 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, Screening visit (n=35) | 11.800 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 3 week Interval, Visit 1 (n=4) | 10.900 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 3 week Interval, Visit 2 (n=4) | 11.050 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 3 week Interval, Visit 3 (n=5) | 14.000 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 3 week Interval, Visit 5 (n=5) | 12.400 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 4 week Interval, Visit 1 (n=29) | 11.000 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 4 week Interval, Visit 2 (n=29) | 10.800 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 1, 4 week Interval, Visit 3 (n=30) | 10.200 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 2, Visit 1 (n=35) | 15.300 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 2, Visit 5 (n=34) | 12.700 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 2, Visit 9 (n=32) | 12.900 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 3a, Visit 1 (n=32) | 12.850 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 3b, Visit 1 (n=31) | 12.900 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 3b, Visit 5 (n=28) | 13.400 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | Part 3b, Visit 9 (n=31) | 13.600 g/L |
| Participants ≥12 Years Old With PK Data Part 1 and Part 3b | Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older | End of Study (n=34) | 13.100 g/L |