Primary Immunodeficiency Diseases (PID)
Conditions
Brief summary
The original purpose of the study is to assess the long-term safety, tolerability, and practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution (IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No. 160603. Following a discussion with the FDA, all participants still active in the study stopped treatment with rHuPH20 to assure safety of the participants participating in the study and went into a safety follow-up. During this safety follow-up period, participants underwent either intravenous (IV) or SC treatment with IGSC, 10%. The IV or SC administration route was at the discretion of the participant and the investigator.
Detailed description
IGSC, 10% is the same product as IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% (IGIV, 10%) quoted in study 160603. IGSC, 10% is abbreviated to IGI, 10% \[IMMUNE GLOBULIN INFUSION (HUMAN), 10%\] In the US the product is licensed (trade name GAMMAGARD LIQUID) for the intravenous (IV) and SC replacement therapy of antibody deficiency in patients with PID. In the EU this product is licensed (trade name KIOVIG) IGSC, 10% with rHuPH20 established name is Innume Glubulin Infusion 10% (Human) with Recombinant Human Hyualuronidase. US trade name is HYQVIA EU trade name is HyQvia
Interventions
BIOLOGICALSC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety)
Participants are to continue on the same doses and treatment intervals of IGSC, 10% adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603 (NCT00814320). After 3 infusions, participants are to change treatment to a 2-week interval, if agreed with participant and investigator. During this safety follow-up period, participants are treated with IGSC, 10% via the SC route. Treatment occurred once every week. The dose was the weekly equivalent of the most recent IV dose (adjusted per body weight) and multiplied by 1.37.
BIOLOGICALSC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety)
Participants are to continue on the same doses and treatment intervals of IGSC, 10% adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603 (NCT00814320). After 3 infusions, participants are to change treatment to a 2-week interval, if agreed with participant and investigator. During this safety follow-up period, participants are treated with IGSC, 10% via the intravenous (IV) route. Treatment occurred once every 3-4 weeks. The weekly dose equivalent was 100% of the most recent IV dose.
BIOLOGICALIV treatment with IGSC, 10%
During this safety follow-up period, participants are treated with IGSC, 10% via the intravenous (IV) route.
Sponsors
Baxalta now part of Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has completed or is about to complete Baxter Clinical Study Protocol No. 160603. Participants who have discontinued rHuPH20 and reverted to intravenous or subcutaneous treatment due to an anti-rHuPH20 antibody also may enroll for long-term safety monitoring. * Participant/caretaker has reviewed, signed and dated informed consent * Participant is willing and able to comply with the requirements of the protocol
Exclusion criteria
* Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in Study 160902 * Participant is scheduled to participate in another non-Baxter clinical study involving an investigational product or investigational device during the course of this study * If female of childbearing potential, participant is pregnant or has a negative pregnancy test and does not agree to employ adequate birth control measures for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual Rate of Serious Bacterial Infections | Throughout the efficacy period only (from 60 to 729 days) | The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20. |
| Annual Rate of All Infections | Throughout the efficacy period only (from 60 to 729 days) | Annualized rate of infections per participant as defined by MedDRA system organ class (SOC) infections and infestations. The point estimate of the annual rate of all infections was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20. |
| Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | Throughout the efficacy period only (from 60 to 729 days) | Immunoglobulin (IgG) steady state trough levels were measured in relation to dose frequency by measuring in relation to treatment interval (2-, 3- or 4-week intervals). Initially participants were administered subcutaneous (SC) infusions of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20) \[or IV infusions of IGSC, 10% only\] at the treatment intervals and dose determined by epoch 2 of study 160603 (3- or 4-week intervals). After 3 treatment intervals (either 3- or 4- week intervals), participants changed to a 2-week treatment interval, if agreed with participant and investigator, with the dose adjusted to 1/2 of the 4-week dose or 2/3 of the 3-week dose, whichever was applicable. The rHuPH20 dose was adjusted relative to the new IGSC, 10% dose in order to achieve a dose ratio of 75 U/g IgG. This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here. This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902). In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603. |
| Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here. This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902). In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603. |
| Number of Participants With AEs Related to Anti-rHuPH20 Titers | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | — |
| Percentage of Participants With AEs Related to Anti-rHuPH20 Titers | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | — |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: CPK - Creatinine Phosphokinase Inc. - Increased Dis - Disease Sml- small |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred Term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Infection - Inf. |
| Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred Term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe) Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: Inc. - Increased Dis. - Disease |
| Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe) |
| The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Separated into age groups as described below and into related (related to either study drug) and not related (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution (IGSC), 10% and recombinant human hyaluronidase (rHuPH20). |
| Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious adverse event; SAE- serious adverse event Severity: Mild; Mod (Moderate); Sev (Severe) Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: Inc. - Increased Dis. - Disease |
| Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe) |
| Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe) |
| Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs. |
| Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs. |
| Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (nsAE) and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs. |
| Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (non-SAE) and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs. |
| Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | — |
| Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe) |
| Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | — |
| Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | — |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted 11 clinical sites in the United States.
Pre-assignment details
66 participants who enrolled from study 160603 were screened and all were enrolled on the study. Of these, 3 participants were treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only i.e. did not receive rHuPH20 during this study.
Participants by arm
| Arm | Count |
|---|---|
| Participants Aged 2 to <12 Years | 4 |
| Participants Aged 12 to <16 Years | 7 |
| Participants Aged 16 to <65 Years | 47 |
| Participants Aged 65 Years and Older | 8 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| IGSC, 10%/rHuPH20 | bone marrow transplant | 1 | 0 |
| IGSC, 10%/rHuPH20 | clinical site closed by sponsor | 6 | 0 |
| IGSC, 10%/rHuPH20 | Death | 1 | 0 |
| IGSC, 10%/rHuPH20 | site elected to exit study | 3 | 0 |
| IGSC, 10%/rHuPH20 | Withdrawal by Subject | 4 | 0 |
| Safety Follow-up | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Participants Aged 2 to <12 Years | Participants Aged 12 to <16 Years | Participants Aged 16 to <65 Years | Participants Aged 65 Years and Older | Total |
|---|---|---|---|---|---|
| Age, Continuous | 10.5 Years | 15.0 Years | 47.0 Years | 71.0 Years | 43.0 Years |
| Region of Enrollment United States | 4 Participants | 7 Participants | 47 Participants | 8 Participants | 66 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 23 Participants | 7 Participants | 32 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 24 Participants | 1 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 63 | 45 / 51 |
| serious Total, serious adverse events | 9 / 63 | 3 / 51 |
Outcome results
Primary
Annual Rate of All Infections
Annualized rate of infections per participant as defined by MedDRA system organ class (SOC) infections and infestations. The point estimate of the annual rate of all infections was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20.
Time frame: Throughout the efficacy period only (from 60 to 729 days)
Population: Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Annual Rate of All Infections | 2.86 Number of infections/year |
Primary
Annual Rate of Serious Bacterial Infections
The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20.
Time frame: Throughout the efficacy period only (from 60 to 729 days)
Population: Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Annual Rate of Serious Bacterial Infections | 0.020 Estimated infections/year |
p-value: <0.0001Poisson
Primary
Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency
Immunoglobulin (IgG) steady state trough levels were measured in relation to dose frequency by measuring in relation to treatment interval (2-, 3- or 4-week intervals). Initially participants were administered subcutaneous (SC) infusions of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20) \[or IV infusions of IGSC, 10% only\] at the treatment intervals and dose determined by epoch 2 of study 160603 (3- or 4-week intervals). After 3 treatment intervals (either 3- or 4- week intervals), participants changed to a 2-week treatment interval, if agreed with participant and investigator, with the dose adjusted to 1/2 of the 4-week dose or 2/3 of the 3-week dose, whichever was applicable. The rHuPH20 dose was adjusted relative to the new IGSC, 10% dose in order to achieve a dose ratio of 75 U/g IgG. This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20.
Time frame: Throughout the efficacy period only (from 60 to 729 days)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | 2-Week Treatment Interval [N=17] | 10.900 g/L |
| All Participants Treated With IGSC, 10% and rHuPH20 | Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | 3-Week Treatment Interval [N=9] | 12.300 g/L |
| All Participants Treated With IGSC, 10% and rHuPH20 | Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | 4-Week Treatment Interval [N=47] | 9.760 g/L |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F).
Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: CPK - Creatinine Phosphokinase Inc. - Increased Dis - Disease Sml- small
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | COPD-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Age Related Macular Degeneration-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | COPD-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthma-non-SAE-NR-Mod | 20 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chronic Sinusitis-non-SAE-NR-Mild | 5 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Tenderness-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chronic Sinusitis-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ataxia-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctival Haemorrhage-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Agitation-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctival Hyperaemia-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Atelectasis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctivitis-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Urea Increased-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctivitis Allergic-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Atrial Fibrillation-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctivitis Allergic-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aldolase Increased-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctivitis Infective-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Atrial Fibrillation-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Constipation-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Tenderness-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Constipation-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | ADHD-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Contusion-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Mass-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Convulsion-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Back Pain-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Convulsion-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Anaphylactic Reaction-non-SAE-R-Sev | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Coombs Direct Test Positive-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Back Pain-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Coombs Test Positive-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abnormal Loss Of Weight-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Coombs Test Positive-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Back Pain-non-SAE-R-Sev | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Corneal Abrasion-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Basal Cell Carcinoma-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Costochondritis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Animal Bite-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Costochondritis-non-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Animal Scratch-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cough-non-SAE-NR-Mild | 10 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blepharochalasis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cough-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acute Sinusitis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cough-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blister-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cryptosporidiosis Infection-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Anxiety-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cyst-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Bicarbonate Decreased-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cyst-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acarodermatitis-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cystitis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood CPK Increased-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cystocele-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Anxiety-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Decreased Appetite-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood CPK Increased-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Decreased Appetite-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Decreased Appetite-non-SAE-R-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Creatinine Increased-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dehydration-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Calcification-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dehydration-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Glucose Increased-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dental Caries-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acarodermatitis-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Depression-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Urine Present-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Depression-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Stenosis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermal Cyst-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Body Tinea-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiomegaly-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Allergic-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bone Pain-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Atopic-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Stenosis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Contact-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Breast Calcifications-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Contact-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acne-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Psoriasiform-non-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Breast Dysplasia-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Device Breakage-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Valve Incompetence-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Device Failure-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bronchiolitis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Diarrhoea-non-SAE-NR-Mild | 15 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain-non-SAE-NR-Mod | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Diarrhoea-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bronchitis-non-SAE-NR-Mild | 11 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Diarrhoea-non-SAE-R-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Valve Incompetence-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dizziness-non-SAE-NR-Mild | 5 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bronchitis-non-SAE-NR-Mod | 11 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dizziness-non-SAE-R-Mild | 5 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acne-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dizziness-non-SAE-R-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Drug Eruption-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Burns Second Degree-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Drug Hypersensitivity-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bursitis-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dry Eye-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Apthous Stomatitis-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dry Eye-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Candidiasis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dry Mouth-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Creatinine Increased-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dry Skin-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiac Failure Congestive-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dysmenorrhoea-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Apthous Stomatitis-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dyspepsia-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiac Murmur-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dysplastic Naevus-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Actinic Keratosis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dyspnoea-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Apthous Stomatitis-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dyspnoea-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiomegaly-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dysuria-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain-non-SAE-NR-Severe | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dysuria-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiomyopathy-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Infection-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Appendicitis-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Infection-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cataract-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Pain-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Actinic Keratosis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Pain-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cataract-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Pruritus-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Application Site Erythema-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eccymosis-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cellulitis-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eccymosis-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Distension-non-SAE-R-Mild | 6 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eczema-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cellulitis-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eczema-non-SAE-NR-Mod | 5 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arteritis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Empty Sella Syndrome-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cellulitis-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Epilepsy-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Activities of Daily Living Impaired-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Epitaxis-non-SAE-NR-Mild | 11 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cellulitis Male Ext. Genital Organ-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Erythema-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arthralgia-non-SAE-NR-Mild | 7 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eschar-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cerebral Sml Vessel Ischaemic Dis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Excoriation-non-SAE-NR-Mild | 8 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Excoriation-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cerumen Impaction-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eye Haemorrhage-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arthralgia-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eye Infection-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cervical Spinal Stenosis-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eye Pain-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acute Sinusitis-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eye Swelling-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chapped Lips-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eyelid Ptosis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arthralgia-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Facial Bones Fracture-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cheilitis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Facial Pain-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain Upper-non-SAE-NR-Mild | 7 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fall-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chest Discomfort-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fall-non-SAE-NR-Sev | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arthropod Bite-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-NR-Mild | 7 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chest Pain-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Basal Cell Carcinoma-non-SAE-NR-Mod | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-NR-Severe | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chest Pain-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-R-Mild | 13 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthenia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-R-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chills-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Femur Fracture-SAE-NR-Sev | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acute Stress Disorder-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fibromyalgia-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chills-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Flatulence-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthenia-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Flushing-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chills-non-SAE-R-Mild | 11 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Folliculitis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain Upper-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Food Poisoning-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cholelithiasis-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Food Poisoning-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthenia-non-SAE-R-Mild | 6 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Foot Fracture-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chondromalacia-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Free Haemoglobin Present-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Adhesiolysis-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Free Haemoglobin Present-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chromaturia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Free Haemoglobin Present-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthenia-non-SAE-R-Mod | 7 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Free Haemoglobin Present-non-SAE-R-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | COPD-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Frequent Bowel Movements-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Hernia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fungal Infection-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | COPD-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fungal Skin Infection-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthma-non-SAE-NR-Mild | 12 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fungal Skin Infection-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Back Pain-non-SAE-R-Sev | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood CPK Increased-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Glucose Increased-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Burns Second Degree-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dizziness-non-SAE-R-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Distension-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Hernia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Mass-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain-non-SAE-NR-Severe | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain Upper-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain Upper-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Tenderness-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Tenderness-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abnormal Loss Of Weight-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acarodermatitis-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acarodermatitis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acne-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acne-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Actinic Keratosis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Actinic Keratosis-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Activities of Daily Living Impaired-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acute Sinusitis-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acute Sinusitis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Acute Stress Disorder-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Adhesiolysis-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Age Related Macular Degeneration-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Agitation-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aldolase Increased-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Animal Bite-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Anaphylactic Reaction-non-SAE-R-Sev | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Animal Scratch-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Anxiety-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Anxiety-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Calcification-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Stenosis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Stenosis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Valve Incompetence-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Aortic Valve Incompetence-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Apthous Stomatitis-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Apthous Stomatitis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Apthous Stomatitis-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Appendicitis-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Application Site Erythema-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arteritis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arthralgia-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arthralgia-non-SAE-NR-Mod | 6 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arthralgia-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Arthropod Bite-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthenia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthenia-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthenia-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthenia-non-SAE-R-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthma-non-SAE-NR-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Asthma-non-SAE-NR-Mod | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ataxia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Atelectasis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Atrial Fibrillation-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Atrial Fibrillation-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | ADHD-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Back Pain-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Back Pain-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Basal Cell Carcinoma-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Basal Cell Carcinoma-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blepharochalasis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blister-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Bicarbonate Decreased-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood CPK Increased-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Creatinine Increased-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Creatinine Increased-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Urea Increased-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Blood Urine Present-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Body Tinea-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bone Pain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Breast Calcifications-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Breast Dysplasia-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bronchiolitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bronchitis-non-SAE-NR-Mild | 5 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bronchitis-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Bursitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Candidiasis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiac Failure Congestive-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiac Murmur-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiomegaly-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiomegaly-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cardiomyopathy-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cataract-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cataract-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cellulitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cellulitis-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cellulitis-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cellulitis Male Ext. Genital Organ-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cerebral Sml Vessel Ischaemic Dis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cerumen Impaction-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cervical Spinal Stenosis-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chapped Lips-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cheilitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chest Discomfort-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chest Pain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chest Pain-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chills-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chills-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chills-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cholelithiasis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chondromalacia-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chromaturia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | COPD-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | COPD-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | COPD-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | COPD-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chronic Sinusitis-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Chronic Sinusitis-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctival Haemorrhage-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctival Hyperaemia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctivitis-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctivitis Allergic-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctivitis Allergic-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Conjunctivitis Infective-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Constipation-non-SAE-NR-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Constipation-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Contusion-non-SAE-NR-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Convulsion-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Convulsion-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Coombs Direct Test Positive-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Coombs Test Positive-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Coombs Test Positive-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Corneal Abrasion-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Costochondritis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Costochondritis-non-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cough-non-SAE-NR-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cough-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cough-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cryptosporidiosis Infection-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cyst-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cyst-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cystitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Cystocele-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Decreased Appetite-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Decreased Appetite-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Decreased Appetite-non-SAE-R-Mild | 8 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dehydration-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dehydration-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dental Caries-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Depression-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Depression-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermal Cyst-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Allergic-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Atopic-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Contact-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Contact-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dermatitis Psoriasiform-non-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Device Breakage-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Device Failure-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Diarrhoea-non-SAE-NR-Mild | 4 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Diarrhoea-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Diarrhoea-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dizziness-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dizziness-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Drug Eruption-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Drug Hypersensitivity-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dry Eye-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dry Eye-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dry Mouth-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dry Skin-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dysmenorrhoea-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dyspepsia-non-SAE-NR-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dysplastic Naevus-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dyspnoea-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dyspnoea-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dysuria-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Dysuria-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Infection-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Infection-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Pain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Pain-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Ear Pruritus-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eccymosis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eccymosis-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eczema-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eczema-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Empty Sella Syndrome-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Epilepsy-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Epitaxis-non-SAE-NR-Mild | 5 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Erythema-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eschar-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Excoriation-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Excoriation-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eye Haemorrhage-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eye Infection-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eye Pain-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eye Swelling-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Eyelid Ptosis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Facial Bones Fracture-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Facial Pain-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fall-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fall-non-SAE-NR-Sev | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-NR-Severe | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-R-Mild | 14 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fatigue-non-SAE-R-Mod | 7 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Femur Fracture-SAE-NR-Sev | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fibromyalgia-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Flatulence-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Flushing-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Folliculitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Food Poisoning-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Food Poisoning-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Foot Fracture-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Free Haemoglobin Present-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Free Haemoglobin Present-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Free Haemoglobin Present-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Free Haemoglobin Present-non-SAE-R-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Frequent Bowel Movements-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Fungal Infection-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Abdominal Pain-non-SAE-R-Mild | 3 Number of AEs |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M).
Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Abscess-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Myalgia-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Bruising-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haematuria-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Discolouration-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis Salmonella-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Discomfort-non-SAE-R-Mild | 8 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haemoglobin Decreased-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Erythema-non-SAE-R-Mild | 22 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Impetigo-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Erythema-non-SAE-R-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haemolysis-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Induration-non-SAE-R-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis Viral-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Mass-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haemorrhoids-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Oedema-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Myalgia-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Pain-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haemorrhoids-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Pain-non-SAE-R-Mild | 78 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis Viral-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Pain-non-SAE-R-Mod | 6 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hand Fracture-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Pruritus-non-SAE-R-Mild | 31 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscular Weakness-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Swelling-non-SAE-R-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Headache-non-SAE-NR-Mild | 22 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Swelling-non-SAE-R-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastrointestinal Viral Infection-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Injection Site Pain-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Headache-non-SAE-NR-Mod | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Injection Site Pain-non-SAE-R-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Myalgia-non-SAE-R-Mild | 23 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Insomnia-non-SAE-NR-Mild | 5 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Headache-non-SAE-R-Mild | 19 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Insomnia-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Intervertebral Disc Degeneration-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Headache-non-SAE-R-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Iron Deficiency Anaemia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscle Strain-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Irritable Bowel Syndrome-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Heart Rate Irregular-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Jejunal Stenosis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Joint Dislocation-non-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Herpes Zoster-non-SAE-NR-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Joint Injury-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Myalgia-non-SAE-R-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Joint Swelling-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hiatus Hernia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Laceration-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Genital Herpes-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Ligament Sprain-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hydrocele-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Ligament Sprain-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Musculoskeletal Pain-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Limb Discomfort-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypercapnia-non-SAE-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Liver Function Test Abnormal-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Genital Herpes-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Local Swelling-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypercholesterolaemia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Local Swelling-non-SAE-R-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastric Stenosis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Localised Infection-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypersensitivity-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Loss Of Consciousness-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gingival Erosion-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lyme Disease-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypertension-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymph Gland Infection-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Mitral Valve Incompetence-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymphadenitis-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypertension-non-SAE-NR-Mod | 6 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymphadenitis Bacterial-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gingivitis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymphadenopathy-non-SAE-NR-Mild | 5 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypertension-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymphopenia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastritis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Malaise-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypoaesthesia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Malaise-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Glaucoma-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Medical Device Pain-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypokalaemia-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Memory Impairment-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Musculoskeletal Pain-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Meniscus Injury-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypothyroidism-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Menstrual Disorder-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Glycosuria-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Mental Status Changes-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypothyroidism-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Micturition Urgency-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Incision Site Pain-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Middle Ear Effusion-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Increased Upper Airway Secretion-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gout-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-NR-Sev | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Inflammation Of Wound-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscular Weakness-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-R-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Influenza-non-SAE-NR-Mod | 6 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Molluscum Contagiosum-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haematochezia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Mouth Ulceration-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Influenza Like Illness-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Mucosal Inflammation-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscle Contractions Involuntary-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Influenza Like Illness-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscle Spasms-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haematospermia-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscle Spasms-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Impetigo-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Mitral Valve Incompetence-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscle Strain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscular Weakness-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscular Weakness-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Musculoskeletal Pain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Musculoskeletal Pain-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Myalgia-non-SAE-NR-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Myalgia-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Myalgia-non-SAE-R-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Myalgia-non-SAE-R-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastric Stenosis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastritis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis Salmonella-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis Viral-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastroenteritis Viral-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastrointestinal Viral Infection-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Genital Herpes-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Genital Herpes-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gingival Erosion-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gingivitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Glaucoma-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Glycosuria-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Gout-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haematochezia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haematospermia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haematuria-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haemoglobin Decreased-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haemolysis-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haemorrhoids-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Haemorrhoids-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hand Fracture-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Headache-non-SAE-NR-Mild | 5 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Headache-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Headache-non-SAE-R-Mild | 34 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Headache-non-SAE-R-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Heart Rate Irregular-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Herpes Zoster-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hiatus Hernia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hydrocele-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypercapnia-non-SAE-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypercholesterolaemia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypersensitivity-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypertension-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypertension-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypertension-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypoaesthesia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypokalaemia-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypothyroidism-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Incision Site Pain-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Increased Upper Airway Secretion-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Inflammation Of Wound-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Influenza-non-SAE-NR-Mod | 4 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Influenza Like Illness-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Influenza Like Illness-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Abscess-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Bruising-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Discolouration-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Discomfort-non-SAE-R-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Erythema-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Erythema-non-SAE-R-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Induration-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Mass-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Oedema-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Pain-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Pain-non-SAE-R-Mild | 17 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Pain-non-SAE-R-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Pruritus-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Swelling-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Infusion Site Swelling-non-SAE-R-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Injection Site Pain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Injection Site Pain-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Insomnia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Insomnia-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Intervertebral Disc Degeneration-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Iron Deficiency Anaemia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Irritable Bowel Syndrome-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Jejunal Stenosis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Joint Dislocation-non-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Joint Injury-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Joint Swelling-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Laceration-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Ligament Sprain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Ligament Sprain-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Limb Discomfort-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Liver Function Test Abnormal-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Local Swelling-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Local Swelling-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Localised Infection-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Loss Of Consciousness-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lyme Disease-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymph Gland Infection-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymphadenitis-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymphadenitis Bacterial-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymphadenopathy-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Lymphopenia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Malaise-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Malaise-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Medical Device Pain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Memory Impairment-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Meniscus Injury-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Menstrual Disorder-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Mental Status Changes-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Micturition Urgency-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Middle Ear Effusion-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-NR-Mod | 4 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-NR-Sev | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-R-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Migraine-non-SAE-R-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Molluscum Contagiosum-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Mouth Ulceration-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Mucosal Inflammation-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Muscle Contractions Involuntary-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Hypothyroidism-non-SAE-NR-Mod | 0 Number of AEs |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z).
Categories presented as Preferred Term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Infection - Inf.
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pneumonia Bacterial-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasal Congestion-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasal Discomfort-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasopharyngitis-non-SAE-NR-Mild | 7 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasopharyngitis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nausea-non-SAE-NR-Mild | 14 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nausea-non-SAE-NR-Mod | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nausea-non-SAE-R-Mild | 25 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nausea-non-SAE-R-Mod | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nephrolithiasis-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nerve Compression-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Neutrophil Count Decreased-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Ocular Hyperaemia-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oedema Peripheral-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oedema Peripheral-non-SAE-NR-Mod | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oedema Peripheral-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oral Candidiasis-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oral Herpes-non-SAE-NR-Mild | 7 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oral Pain-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oral Pain-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Orchitis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oropharyngeal Pain-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Osteoarthritis-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Osteoarthritis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Osteopenia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Osteoporosis-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Otitis Externa-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Otitis Externa-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Otitis Media-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pain-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pain-non-SAE-R-Mild | 7 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pain In Extremity-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pain In Extremity-non-SAE-R-Sev | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Palpitations-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Panic Attack-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Papule-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Paraesthesia-non-SAE-R-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Paranasal Cyst-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pelvic Pain-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pericardial Effusion-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Perineurial Cyst-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Periodontal Disease-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pharyngitis-non-SAE-NR-Mild | 6 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pharyngitis-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pharyngitis Streptococcal-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pleural Effusion-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pleural Effusion-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pneumonia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasal Congestion-non-SAE-NR-Mild | 11 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pneumonia Pseudomonas Aeruginosa-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pollakiuria-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pollakiuria-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Polycystic Ovaries-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Post Procedural Complication-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Post Procedural Haemorrhage-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Post Procedural Swelling-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Procedural Nausea-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Procedural Pain-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Procedural Pain-non-SAE-NR-Mod | 9 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Proctalgia-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Productive Cough-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Protein Urine Present-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus Allergic-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus Generalised-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pulmonary Hypertension-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pulmonary Hypertension-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pulmonary Vascular Disorder-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Puncture Site Pain-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Puncture Site Pain-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Purpura Senile-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyogenic Granuloma-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyrexia-non-SAE-NR-Mild | 11 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyrexia-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyrexia-non-SAE-R-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyuria-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rales-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rash-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rash Generalised-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rectal Polyp-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Red Blood Cells Urine Positive-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Respiratory Tract Infection-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Respiratory Tract Infection-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Restless Legs Syndrome-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rhinitis-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rhinitis Perennial-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rhinorrhoea-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rhinorrhoea-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Right Atrial Dilatation-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rotator Cuff Syndrome-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scab-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scar-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scoliosis-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scratch-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scrotal Swelling-non-SAE-R-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Seborrhoeic Keratosis-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sinus Congestion-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sinus Headache-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sinusitis-non-SAE-NR-Mild | 34 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sinusitis-non-SAE-NR-Mod | 29 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Skin Hyperpigmentation-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Skin Lesion-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Skin Mass-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sleep Apnoea Syndrome-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Slow Speech-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Solar Lentigo-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Somnolence-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Speech Disorder-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Spermatocele-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Spinal Compression Fracture-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Spinal Meningeal Cyst-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Spinal Osteoarthritis-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Squamous Cell Carcinoma-non-SAE-NR-Mod | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Stress-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Suicide Attempt-non-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sunburn-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Swelling Face-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Swelling Face-non-SAE-NR-Sev | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Swollen Tongue-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Synovial Cyst-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tachycardia-non-SAE-NR-Mild | 5 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tachycardia-non-SAE-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tendon Disorder-non-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tendonitis-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tendonitis-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Testicular Microlithiasis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Testicular Pain-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Thermal Burn-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Thinking Abnormal-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Thrombocytopenia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tibia Fracture-non-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tinea Cruris-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tinea Infection-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Abscess-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Abscess-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Fracture-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Infection-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Infection-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Toothache-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Toxicity To Various Agents-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tracheal Stenosis-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Transient Ischaemic Attack-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Traumatic Haematoma-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tricuspid Valve Incompetence-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Trigeminal Neuralgia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tympanic Membrane Scarring-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Type 2 Diabetes Mellitus-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper Limb Fracture-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper Limb Fracture-non-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-NR-Mild | 16 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-NR-Mod | 13 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper-Airway Cough Syndrome-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urethritis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urinary Tract Infection-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urinary Tract Infection-non-SAE-NR-Mod | 6 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urticaria-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urticaria-non-SAE-R-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Uterine Polyp-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vaginal Prolapse-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vaginitis Bacterial-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Varicose Vein-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vasomotor Rhinitis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vein Pain-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Ventricular Hypokinesia-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vessel Puncture Site Bruise-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Infection-non-SAE-NR-Mild | 3 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Infection-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Pharyngitis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Pharyngitis-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Rash-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Upper Respiratory Tract Inf.-non-SAE-NR-Mild | 29 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Upper Respiratory Tract Inf.-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vision Blurred-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vitamin B12 Deficiency-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vitamin D Decreased-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vitamin D Deficiency-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vitamin D Deficiency-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vomiting-non-SAE-NR-Mild | 13 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vomiting-non-SAE-NR-Mod | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vomiting-non-SAE-R-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vulvar Dysplasia-non-SAE-NR-Mild | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vulvovaginal Candidiasis-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-NR-Mild | 4 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-NR-Mod | 2 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wheezing-non-SAE-NR-Mod | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-NR-Mild | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-NR-Sev | 1 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wound-non-SAE-NR-Mild | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wrist Fracture-non-SAE-NR-Mod | 0 Number of AEs |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Xeroderma-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Transient Ischaemic Attack-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasal Congestion-non-SAE-NR-Mild | 5 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scratch-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasal Congestion-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wrist Fracture-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasal Discomfort-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scrotal Swelling-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasopharyngitis-non-SAE-NR-Mild | 5 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Traumatic Haematoma-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nasopharyngitis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Seborrhoeic Keratosis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nausea-non-SAE-NR-Mild | 5 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Infection-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nausea-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sinus Congestion-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nausea-non-SAE-R-Mild | 12 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tricuspid Valve Incompetence-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nausea-non-SAE-R-Mod | 7 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sinus Headache-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nephrolithiasis-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vomiting-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Nerve Compression-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sinusitis-non-SAE-NR-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Neutrophil Count Decreased-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Trigeminal Neuralgia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Ocular Hyperaemia-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sinusitis-non-SAE-NR-Mod | 13 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oedema Peripheral-non-SAE-NR-Mild | 4 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Pharyngitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oedema Peripheral-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Skin Hyperpigmentation-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oedema Peripheral-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tympanic Membrane Scarring-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oral Candidiasis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Skin Lesion-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oral Herpes-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wheezing-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oral Pain-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Skin Mass-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oral Pain-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Type 2 Diabetes Mellitus-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Orchitis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sleep Apnoea Syndrome-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Oropharyngeal Pain-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Pharyngitis-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Osteoarthritis-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Slow Speech-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Osteoarthritis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper Limb Fracture-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Osteopenia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Solar Lentigo-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Osteoporosis-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vomiting-non-SAE-R-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Otitis Externa-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Somnolence-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Otitis Externa-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper Limb Fracture-non-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Otitis Media-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Speech Disorder-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pain-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Rash-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pain-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Spermatocele-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pain In Extremity-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-NR-Mild | 8 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pain In Extremity-non-SAE-R-Sev | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Spinal Compression Fracture-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Palpitations-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wound-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Panic Attack-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Spinal Meningeal Cyst-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Papule-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Paraesthesia-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Spinal Osteoarthritis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Paranasal Cyst-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Upper Respiratory Tract Inf.-non-SAE-NR-Mild | 5 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pelvic Pain-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Squamous Cell Carcinoma-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pericardial Effusion-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Upper-Airway Cough Syndrome-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Perineurial Cyst-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Stress-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Periodontal Disease-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vulvar Dysplasia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pharyngitis-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Suicide Attempt-non-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pharyngitis-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urethritis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pharyngitis Streptococcal-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Sunburn-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pleural Effusion-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Upper Respiratory Tract Inf.-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pleural Effusion-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Swelling Face-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pneumonia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urinary Tract Infection-non-SAE-NR-Mild | 4 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pneumonia Bacterial-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Swelling Face-non-SAE-NR-Sev | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pneumonia Pseudomonas Aeruginosa-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pollakiuria-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Swollen Tongue-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pollakiuria-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urinary Tract Infection-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Polycystic Ovaries-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Synovial Cyst-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Post Procedural Complication-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vision Blurred-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Post Procedural Haemorrhage-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tachycardia-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Post Procedural Swelling-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urticaria-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Procedural Nausea-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tachycardia-non-SAE-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Procedural Pain-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vulvovaginal Candidiasis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Procedural Pain-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tendon Disorder-non-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Proctalgia-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Urticaria-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Productive Cough-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tendonitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Protein Urine Present-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vitamin B12 Deficiency-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus-non-SAE-NR-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tendonitis-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Uterine Polyp-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus-non-SAE-R-Mild | 3 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Testicular Microlithiasis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus Allergic-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Xeroderma-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pruritus Generalised-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Testicular Pain-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pulmonary Hypertension-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vaginal Prolapse-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pulmonary Hypertension-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Thermal Burn-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pulmonary Vascular Disorder-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vitamin D Decreased-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Puncture Site Pain-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Thinking Abnormal-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Puncture Site Pain-non-SAE-NR-Mod | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vaginitis Bacterial-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Purpura Senile-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Thrombocytopenia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyogenic Granuloma-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyrexia-non-SAE-NR-Mild | 5 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tibia Fracture-non-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyrexia-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Varicose Vein-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyrexia-non-SAE-R-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tinea Cruris-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Pyuria-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vitamin D Deficiency-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rales-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tinea Infection-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rash-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vasomotor Rhinitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rash Generalised-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Abscess-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rectal Polyp-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Red Blood Cells Urine Positive-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Abscess-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vein Pain-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Fracture-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Respiratory Tract Infection-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vitamin D Deficiency-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Respiratory Tract Infection-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Infection-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Restless Legs Syndrome-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Ventricular Hypokinesia-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rhinitis-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tooth Infection-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rhinitis Perennial-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-NR-Mod | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rhinorrhoea-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Toothache-non-SAE-NR-Mod | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rhinorrhoea-non-SAE-R-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vessel Puncture Site Bruise-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Right Atrial Dilatation-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Toxicity To Various Agents-SAE-NR-Sev | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Rotator Cuff Syndrome-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Vomiting-non-SAE-NR-Mild | 2 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scab-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Tracheal Stenosis-non-SAE-NR-Mild | 1 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scar-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Viral Infection-non-SAE-NR-Mild | 0 Number of AEs |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Scoliosis-non-SAE-NR-Mild | 1 Number of AEs |
Secondary
Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20
Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here. This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902). In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603.
Time frame: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)
Population: Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Binding antibodies (>=1:160) | 13 Number of participants |
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Neutralizing antibodies | 0 Number of participants |
Secondary
Number of Participants With AEs Related to Anti-rHuPH20 Titers
Time frame: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)
Population: All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Number of Participants With AEs Related to Anti-rHuPH20 Titers | 12 Number of participants |
Secondary
Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study | Including Infections | 8.8 Percentage of infusions |
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study | Excluding Infections | 8.7 Percentage of infusions |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study | Excluding Infections | 3.7 Percentage of infusions |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study | Including Infections | 3.7 Percentage of infusions |
Secondary
Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion | Including Infections | 3.4 Percentage of infusions |
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion | Excluding Infections | 2.9 Percentage of infusions |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion | Including Infections | 4.7 Percentage of infusions |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion | Excluding Infections | 4.0 Percentage of infusions |
Secondary
Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Percentage of infusion rates reduced | 1.3 Percentage of infusions |
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Percentage of infusions interrupted | 0.8 Percentage of infusions |
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Percentage of infusions stopped | 0.1 Percentage of infusions |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Percentage of infusion rates reduced | 0.3 Percentage of infusions |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Percentage of infusions interrupted | 0.2 Percentage of infusions |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Percentage of infusions stopped | 0.2 Percentage of infusions |
Secondary
Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20
Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here. This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902). In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603.
Time frame: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)
Population: Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Binding antibodies (>=1:160) | 19.7 Percentage of participants |
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Neutralizing antibodies | 0 Percentage of participants |
Secondary
Percentage of Participants With AEs Related to Anti-rHuPH20 Titers
Time frame: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)
Population: All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Percentage of Participants With AEs Related to Anti-rHuPH20 Titers | 92.3 Percentage of participants |
Secondary
Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related)
Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs.
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Total | 0.103 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Mild | 0.085 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Moderate | 0.014 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Severe | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Total | 0.099 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Mild | 0.085 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Moderate | 0.014 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Severe | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Total | 0.099 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Mild | 0.183 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Moderate | 0.019 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Total | 0.202 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Mild | 0.098 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Moderate | 0.004 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Moderate | 0.033 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Severe | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Moderate | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Moderate | 0.033 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Total | 0.032 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Severe | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Mild | 0.151 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Total | 0.221 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Moderate | 0.033 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Total | 0.189 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Severe | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Severe | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Total | 0.189 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Mild | 0.182 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Mild | 0.151 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Mild | 0.032 Number of AEs per infusion |
Secondary
Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion
Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (non-SAE) and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs.
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, non-SAE, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, non-SAE, Moderate | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Moderate | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, non-SAE, Mild | 0.123 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, non-SAE, Mild | 0.233 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, non-SAE, Moderate | 0.044 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, non-SAE, Mild | 0.098 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total non-SAE, Total | 0.278 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Moderate | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Total | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, non-SAE, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, non-SAE, Total | 0.103 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, non-SAE, Mild | 0.135 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, non-SAE, Moderate | 0.039 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, non-SAE, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, non-SAE, Total | 0.175 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Total | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, non-SAE, Moderate | 0.034 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, non-SAE, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, non-SAE, Total | 0.158 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Moderate | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Total | 0.001 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, non-SAE, Total | 0.204 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, non-SAE, Mild | 0.030 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, non-SAE, Total | 0.033 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, non-SAE, Total | 0.221 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Severe | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Total | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, non-SAE, Mild | 0.164 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, non-SAE, Mild | 0.156 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, non-SAE, Moderate | 0.043 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, non-SAE, Mild | 0.194 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, non-SAE, Moderate | 0.052 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, non-SAE, Moderate | 0.055 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Moderate | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, non-SAE, Severe | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, non-SAE, Severe | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total non-SAE, Total | 0.254 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, non-SAE, Severe | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Moderate | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Moderate | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Severe | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Total | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Total | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, non-SAE, Moderate | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Severe | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, non-SAE, Severe | 0 Number of AEs per infusion |
Secondary
Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related)
Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs.
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Mild | 4.635 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Moderate | 0.476 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Severe | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Total | 5.127 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local nsAEs, Mild | 2.476 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Moderate | 0.111 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Severe | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Total | 2.603 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Mild | 2.159 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Moderate | 0.365 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Severe | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Total | 2.524 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Mild | 2.159 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Moderate | 0.365 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Severe | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Total | 2.524 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Total | 2.216 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Mild | 2.137 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Mild | 1.765 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Moderate | 0.392 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Mild | 1.765 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Severe | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Moderate | 0.392 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Total AEs, Total | 2.588 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Severe | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local nsAEs, Mild | 0.373 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Severe | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Moderate | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs excluding infections, Moderate | 0.392 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Severe | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Systemic AEs including infections, Total | 2.216 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Local AEs, Total | 0.373 Number of AEs per participant |
Secondary
Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion
Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (nsAE) and Severity (Mild, Moderate, Severe, Total). All of these adverse events are non-serious AEs.
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Total | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, nsAE, Severe | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Moderate | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, nsAE, Total | 2.619 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Moderate | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, nsAE, Moderate | 1.111 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, nsAE, Mild | 5.921 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total nsAE, Total | 7.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Severe | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Total | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, nsAE, Mild | 2.492 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, nsAE, Moderate | 0.111 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, nsAE, Severe | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, nsAE, Mild | 3.429 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, nsAE, Moderate | 1.000 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, nsAE, Severe | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, nsAE, Total | 4.444 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Moderate | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Severe | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Total | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, nsAE, Mild | 3.111 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, nsAE, Moderate | 0.873 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, nsAE, Severe | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, nsAE, Total | 4.000 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Severe | 0.016 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, nsAE, Moderate | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, nsAE, Moderate | 0.647 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, nsAE, Severe | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, nsAE, Severe | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total nsAE, Total | 2.980 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, nsAE, Severe | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Severe | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, nsAE, Total | 0.392 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, nsAE, Mild | 1.922 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, nsAE, Total | 2.588 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, nsAE, Moderate | 0.608 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Severe | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, nsAE, Moderate | 0.608 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Total | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Total | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, nsAE, Mild | 2.275 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, nsAE, Severe | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Moderate | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, SAE, Moderate | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Severe | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, nsAE, Total | 2.588 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Total, SAE, Total | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic excluding infections, nsAE, Mild | 1.922 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Local, nsAE, Mild | 0.353 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion | Systemic including infections, SAE, Moderate | 0 Number of AEs per participant |
Secondary
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).
Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious adverse event; SAE- serious adverse event Severity: Mild; Mod (Moderate); Sev (Severe) Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: Inc. - Increased Dis. - Disease
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthma-non-SAE-Mild | 0.008 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatine Phosphokinase Inc.-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchitis-non-SAE-Mod | 0.007 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Pain-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chromaturia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Excoriation-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fall-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Distension-non-SAE-Mild | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Hernia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Mass-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Mod | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Severe | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain Upper-non-SAE-Mild | 0.005 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Tenderness-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abnormal Loss of Weight-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acarodermatitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acarodermatitis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acne-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acne-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Actinic Keratosis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Actinic Keratosis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Activities of Daily Living Impaired-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Sinusitis-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Sinusitis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Stress Disorder-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Adhesiolysis-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Age-Related Macular Degeneration-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Agitation-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aldolase Increased-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anaphylactic Reaction-non-SAE-Sev | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Animal Bite-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Animal Scratch-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anxiety-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anxiety-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Calcification-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Stenosis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Stenosis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Valve Incompetence-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Valve Incompetence-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aphthous Stomatitis-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aphthous Stomatitis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Appendicitis-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Application Site Erythema-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arteritis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthralgia-non-SAE-Mild | 0.005 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthralgia-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthropod Bite-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthenia-non-SAE-Mild | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthenia-non-SAE-Mod | 0.006 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Basal Cell Carcinoma-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthma-non-SAE-Mod | 0.013 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ataxia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atelectasis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atrial Fibrillation-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atrial Fibrillation-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | ADHD-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Sev | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Basal Cell Carcinoma-non-SAE-Mod | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blepharochalasis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blister-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Bicarbonate Decreased-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatine Phosphokinase Inc.-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatinine Increased-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Glucose Increased-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Urea Increased-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Urine Present-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Body Tinea-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bone Pain-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Breast Calcifications-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Breast Dysplasia-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchiolitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchitis-non-SAE-Mild | 0.007 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Burns Second Degree-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bursitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Candidiasis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiac Failure Congestive-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiac Murmur-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomegaly-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomegaly-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomyopathy-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cataract-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cataract-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis Of Male Ext Genital Organ-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cerebral Small Vessel Ischaemic Dis.-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cerumen Impaction-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cervical Spinal Stenosis-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chapped Lips-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cheilitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Discomfort-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Pain-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chills-non-SAE-Mild | 0.008 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chills-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cholelithiasis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chondromalacia-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chronic Sinusitis-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chronic Sinusitis-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctival Haemorrhage-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctival Hyperaemia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Allergic-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Allergic-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Infective-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Constipation-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Constipation-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Contusion-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Convulsion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Convulsion-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Coombs Direct Test Positive-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Coombs Test Positive-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Corneal Abrasion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Costochondritis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Costochondritis-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cough-non-SAE-Mild | 0.007 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cough-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cryptosporidiosis Infection-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cyst-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cyst-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cystitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cystocele-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Decreased Appetite-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Decreased Appetite-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dehydration-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dehydration-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dental Caries-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Depression-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Depression-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermal Cyst-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Allergic-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Atopic-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Contact-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Contact-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Psoriasiform-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Device Breakage-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Device Failure-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Diarrhoea-non-SAE-Mild | 0.011 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Diarrhoea-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dizziness-non-SAE-Mild | 0.006 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dizziness-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Drug Eruption-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Drug Hypersensitivity-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Eye-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Eye-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Mouth-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Skin-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysmenorrhoea-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspepsia-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysplastic Naevus-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspnoea-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspnoea-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysuria-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysuria-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Infection-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Infection-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pain-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pain-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pruritus-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ecchymosis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ecchymosis-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eczema-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eczema-non-SAE-Mod | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Empty Sella Syndrome-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Epilepsy-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Epistaxis-non-SAE-Mild | 0.007 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Erythema-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eschar-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Excoriation-non-SAE-Mild | 0.005 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Haemorrhage-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Infection-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Swelling-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eyelid Ptosis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Facial Bones Fracture-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Facial Pain-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fall-non-SAE-Sev | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Mild | 0.013 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Mod | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Femur Fracture-SAE-Sev | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fibromyalgia-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Flatulence-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Flushing-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Folliculitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Food Poisoning-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Food Poisoning-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Foot Fracture-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Free Haemoglobin Present-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Free Haemoglobin Present-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Frequent Bowel Movements-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fungal Infection-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fungal Skin Infection-non-SAE-Mild | 0.001 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Basal Cell Carcinoma-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatine Phosphokinase Inc.-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Eye-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchitis-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Excoriation-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chromaturia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Corneal Abrasion-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Eye-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Facial Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fungal Infection-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Distension-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chronic Sinusitis-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Hernia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Mouth-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Mass-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chronic Sinusitis-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Mild | 0.007 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Haemorrhage-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctival Haemorrhage-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Severe | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Skin-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain Upper-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctival Hyperaemia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Tenderness-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fibromyalgia-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abnormal Loss of Weight-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acarodermatitis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysmenorrhoea-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acarodermatitis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Allergic-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acne-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Infection-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acne-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Allergic-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Actinic Keratosis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspepsia-non-SAE-Mild | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Actinic Keratosis-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Infective-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Activities of Daily Living Impaired-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Foot Fracture-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Sinusitis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Constipation-non-SAE-Mild | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Sinusitis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysplastic Naevus-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Stress Disorder-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Constipation-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Adhesiolysis-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Pain-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Age-Related Macular Degeneration-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Contusion-non-SAE-Mild | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Agitation-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspnoea-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aldolase Increased-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Convulsion-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anaphylactic Reaction-non-SAE-Sev | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Flatulence-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Animal Bite-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Convulsion-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Animal Scratch-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspnoea-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anxiety-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Coombs Direct Test Positive-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anxiety-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Swelling-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Calcification-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Coombs Test Positive-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Stenosis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysuria-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Stenosis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Frequent Bowel Movements-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Valve Incompetence-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Costochondritis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Valve Incompetence-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysuria-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aphthous Stomatitis-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Costochondritis-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aphthous Stomatitis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eyelid Ptosis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Appendicitis-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cough-non-SAE-Mild | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Application Site Erythema-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Infection-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arteritis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cough-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthralgia-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Flushing-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthralgia-non-SAE-Mod | 0.010 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cryptosporidiosis Infection-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthropod Bite-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Infection-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthenia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cyst-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthenia-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Facial Bones Fracture-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthma-non-SAE-Mild | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cyst-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthma-non-SAE-Mod | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ataxia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cystitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atelectasis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Free Haemoglobin Present-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atrial Fibrillation-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cystocele-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atrial Fibrillation-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | ADHD-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Decreased Appetite-non-SAE-Mild | 0.013 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fall-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Decreased Appetite-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Sev | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pruritus-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Basal Cell Carcinoma-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dehydration-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blepharochalasis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Folliculitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blister-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dehydration-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Bicarbonate Decreased-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ecchymosis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatine Phosphokinase Inc.-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dental Caries-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatinine Increased-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fall-non-SAE-Sev | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Glucose Increased-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Depression-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Urea Increased-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ecchymosis-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Urine Present-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Depression-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Body Tinea-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fungal Skin Infection-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bone Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermal Cyst-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Breast Calcifications-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eczema-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Breast Dysplasia-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchiolitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Mild | 0.025 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchitis-non-SAE-Mild | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Allergic-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Burns Second Degree-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eczema-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bursitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Atopic-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Candidiasis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Food Poisoning-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiac Failure Congestive-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Contact-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiac Murmur-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Empty Sella Syndrome-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomegaly-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Contact-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomegaly-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Mod | 0.013 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomyopathy-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Psoriasiform-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cataract-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Epilepsy-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cataract-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Device Breakage-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Free Haemoglobin Present-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Device Failure-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Epistaxis-non-SAE-Mild | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis Of Male Ext Genital Organ-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Diarrhoea-non-SAE-Mild | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cerebral Small Vessel Ischaemic Dis.-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cerumen Impaction-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Diarrhoea-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cervical Spinal Stenosis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Erythema-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chapped Lips-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dizziness-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cheilitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Food Poisoning-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Discomfort-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dizziness-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eschar-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chills-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Drug Eruption-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chills-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Femur Fracture-SAE-Sev | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cholelithiasis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Drug Hypersensitivity-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chondromalacia-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Excoriation-non-SAE-Mild | 0.002 Number of AEs per infusion |
Secondary
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).
Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Erythema-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Genital Herpes-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Induration-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Headache-non-SAE-Mod | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Mass-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastritis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Oedema-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Heart Rate Irregular-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pain-non-SAE-Mild | 0.049 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gingival Erosion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pain-non-SAE-Mod | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Herpes Zoster-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pruritus-non-SAE-Mild | 0.019 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Viral-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Swelling-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hiatus Hernia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Swelling-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gingivitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Injection Site Pain-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hydrocele-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Insomnia-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Musculoskeletal Pain-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Insomnia-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypercapnia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Intervertebral Disc Degeneration-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Glaucoma-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Iron Deficiency Anaemia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypercholesterolaemia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Irritable Bowel Syndrome-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Viral-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Jejunal Stenosis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypersensitivity-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Dislocation-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Glycosuria-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Injury-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Swelling-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Laceration-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-non-SAE-Mod | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Ligament Sprain-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gout-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Ligament Sprain-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Limb Discomfort-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematochezia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Liver Function Test Abnormal-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypoaesthesia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Local Swelling-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrointestinal Viral Infection-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Localised Infection-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypokalaemia-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Loss Of Consciousness-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematospermia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lyme Disease-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypothyroidism-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymph Gland Infection-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastric Stenosis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenitis-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypothyroidism-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenitis Bacterial-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematuria-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenopathy-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Impetigo-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphopenia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Malaise-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Incision Site Pain-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Medical Device Pain-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemoglobin Decreased-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Memory Impairment-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Increased Upper Airway Secretion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Meniscus Injury-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Menstrual Disorder-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Inflammation Of Wound-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mental Status Changes-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemolysis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Micturition Urgency-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza-non-SAE-Mod | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Middle Ear Effusion-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza Like Illness-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Mod | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemorrhoids-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Sev | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza Like Illness-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mitral Valve Incompetence-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Myalgia-non-SAE-Mild | 0.016 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Molluscum Contagiosum-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Abscess-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mouth Ulceration-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemorrhoids-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mucosal Inflammation-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Bruising-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Contractions Involuntary-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Genital Herpes-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Spasms-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Discolouration-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Strain-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hand Fracture-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscular Weakness-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Discomfort-non-SAE-Mild | 0.005 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscular Weakness-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Salmonella-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Musculoskeletal Pain-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Erythema-non-SAE-Mild | 0.014 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Myalgia-non-SAE-Mod | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Headache-non-SAE-Mild | 0.026 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Myalgia-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Musculoskeletal Pain-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Myalgia-non-SAE-Mild | 0.010 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastric Stenosis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastritis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Salmonella-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Viral-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Viral-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrointestinal Viral Infection-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Genital Herpes-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Genital Herpes-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gingival Erosion-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gingivitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Glaucoma-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Glycosuria-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematochezia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematospermia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematuria-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemoglobin Decreased-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemolysis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemorrhoids-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemorrhoids-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hand Fracture-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Headache-non-SAE-Mild | 0.065 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Headache-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Heart Rate Irregular-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Herpes Zoster-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hiatus Hernia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hydrocele-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypercapnia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypercholesterolaemia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypersensitivity-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypoaesthesia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypokalaemia-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypothyroidism-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypothyroidism-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Impetigo-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Incision Site Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Increased Upper Airway Secretion-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Inflammation Of Wound-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza-non-SAE-Mod | 0.007 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza Like Illness-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza Like Illness-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Abscess-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Bruising-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Discolouration-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Discomfort-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Erythema-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Erythema-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Induration-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Mass-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Oedema-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pain-non-SAE-Mild | 0.028 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pain-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pruritus-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Swelling-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Swelling-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Injection Site Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Insomnia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Insomnia-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Intervertebral Disc Degeneration-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Iron Deficiency Anaemia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Irritable Bowel Syndrome-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Jejunal Stenosis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Dislocation-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Injury-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Swelling-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Laceration-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Ligament Sprain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Ligament Sprain-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Limb Discomfort-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Liver Function Test Abnormal-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Local Swelling-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Localised Infection-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Loss Of Consciousness-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lyme Disease-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymph Gland Infection-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenitis-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenitis Bacterial-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenopathy-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphopenia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Malaise-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Medical Device Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Memory Impairment-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Meniscus Injury-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Menstrual Disorder-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mental Status Changes-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Micturition Urgency-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Middle Ear Effusion-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Mod | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Sev | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mitral Valve Incompetence-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Molluscum Contagiosum-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mouth Ulceration-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mucosal Inflammation-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Contractions Involuntary-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Spasms-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Strain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscular Weakness-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscular Weakness-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Musculoskeletal Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gout-non-SAE-Mod | 0 Number of AEs per infusion |
Secondary
Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).
Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Abscess-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Ocular Hyperaemia-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Infection-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Right Atrial Dilatation-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rotator Cuff Syndrome-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scab-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinusitis-non-SAE-Mild | 0.021 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swelling Face-non-SAE-Sev | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Trigeminal Neuralgia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urinary Tract Infection-non-SAE-Mod | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vaginitis Bacterial-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Decreased-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Deficiency-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Deficiency-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvar Dysplasia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Congestion-non-SAE-Mild | 0.007 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Congestion-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Discomfort-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasopharyngitis-non-SAE-Mild | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasopharyngitis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nausea-non-SAE-Mild | 0.024 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nausea-non-SAE-Mod | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nephrolithiasis-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nerve Compression-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oedema Peripheral-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oedema Peripheral-non-SAE-Mod | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Candidiasis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Herpes-non-SAE-Mild | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Orchitis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oropharyngeal Pain-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoarthritis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoarthritis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteopenia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoporosis-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Externa-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Externa-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Media-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain-non-SAE-Mild | 0.006 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain In Extremity-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain In Extremity-non-SAE-Sev | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Palpitations-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Panic Attack-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Papule-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Paraesthesia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Paranasal Cyst-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pelvic Pain-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pericardial Effusion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Perineurial Cyst-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Periodontal Disease-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis-non-SAE-Mild | 0.004 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis Streptococcal-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pleural Effusion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pleural Effusion-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia Bacterial-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia Pseudomonas Aeruginosa-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pollakiuria-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pollakiuria-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Polycystic Ovaries-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Complication-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Haemorrhage-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Swelling-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Nausea-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Pain-non-SAE-Mod | 0.006 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Proctalgia-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Productive Cough-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Protein Urine Present-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus Allergic-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus Generalised-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Hypertension-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Hypertension-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Vascular Disorder-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Puncture Site Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Puncture Site Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Purpura Senile-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyogenic Granuloma-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyrexia-non-SAE-Mild | 0.009 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyrexia-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyuria-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rales-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rash-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rash Generalised-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rectal Polyp-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Red Blood Cells Urine Positive-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Infection-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Restless Legs Syndrome-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinitis Perennial-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinorrhoea-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scar-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scoliosis-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scratch-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scrotal Swelling-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Seborrhoeic Keratosis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinus Congestion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinus Headache-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinusitis-non-SAE-Mod | 0.018 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Hyperpigmentation-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Lesion-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Mass-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sleep Apnoea Syndrome-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Slow Speech-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Solar Lentigo-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Somnolence-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Speech Disorder-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spermatocele-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Compression Fracture-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Meningeal Cyst-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Osteoarthritis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Squamous Cell Carcinoma-non-SAE-Mod | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Stress-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Suicide Attempt-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sunburn-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swelling Face-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swollen Tongue-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Synovial Cyst-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tachycardia-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tachycardia-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendon Disorder-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendonitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendonitis-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Testicular Microlithiasis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Testicular Pain-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thermal Burn-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thinking Abnormal-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thrombocytopenia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tibia Fracture-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tinea Cruris-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tinea Infection-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Abscess-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Neutrophil Count Decreased-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Fracture-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Infection-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Infection-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Toothache-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Toxicity To Various Agents-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tracheal Stenosis-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Transient Ischaemic Attack-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Traumatic Haematoma-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tricuspid Valve Incompetence-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tympanic Membrane Scarring-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Type 2 Diabetes Mellitus-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Limb Fracture-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Limb Fracture-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-Mild | 0.010 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-Mod | 0.008 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper-Airway Cough Syndrome-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urethritis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urinary Tract Infection-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urticaria-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Uterine Polyp-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vaginal Prolapse-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Varicose Vein-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vasomotor Rhinitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vein Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Ventricular Hypokinesia-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vessel Puncture Site Bruise-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Infection-non-SAE-Mild | 0.002 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Infection-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Pharyngitis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Pharyngitis-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Rash-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Upper Respiratory Tract Inf.-non-SAE-Mild | 0.018 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Upper Respiratory Tract Inf-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vision Blurred-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin B12 Deficiency-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vomiting-non-SAE-Mild | 0.008 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vomiting-non-SAE-Mod | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Candidiasis-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-Mild | 0.003 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wheezing-non-SAE-Mod | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-Mild | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-Sev | 0.001 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wound-non-SAE-Mild | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wrist Fracture-non-SAE-Mod | 0 Number of AEs per infusion |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Xeroderma-non-SAE-Mild | 0.001 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Deficiency-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Neutrophil Count Decreased-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Infection-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Ocular Hyperaemia-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Abscess-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Infection-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Restless Legs Syndrome-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Right Atrial Dilatation-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vein Pain-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rotator Cuff Syndrome-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinus Headache-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Fracture-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinusitis-non-SAE-Mild | 0.005 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swelling Face-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinitis Perennial-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Toxicity To Various Agents-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wheezing-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Trigeminal Neuralgia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urinary Tract Infection-non-SAE-Mild | 0.007 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinorrhoea-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urinary Tract Infection-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scab-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vaginitis Bacterial-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Infection-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Decreased-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scar-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Deficiency-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Ventricular Hypokinesia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scoliosis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvar Dysplasia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Infection-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Congestion-non-SAE-Mild | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scratch-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Congestion-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vomiting-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Discomfort-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scrotal Swelling-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasopharyngitis-non-SAE-Mild | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Toothache-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasopharyngitis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Seborrhoeic Keratosis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nausea-non-SAE-Mild | 0.028 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vessel Puncture Site Bruise-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nausea-non-SAE-Mod | 0.013 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinus Congestion-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nephrolithiasis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wound-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nerve Compression-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tracheal Stenosis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oedema Peripheral-non-SAE-Mild | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinusitis-non-SAE-Mod | 0.022 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oedema Peripheral-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Infection-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Candidiasis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Hyperpigmentation-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Herpes-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Transient Ischaemic Attack-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Pain-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Lesion-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Pain-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vomiting-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Orchitis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Mass-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oropharyngeal Pain-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Traumatic Haematoma-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoarthritis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sleep Apnoea Syndrome-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoarthritis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Infection-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteopenia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Slow Speech-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoporosis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tricuspid Valve Incompetence-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Externa-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Solar Lentigo-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Externa-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Media-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Somnolence-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tympanic Membrane Scarring-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain In Extremity-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Speech Disorder-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain In Extremity-non-SAE-Sev | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Pharyngitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Palpitations-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spermatocele-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Panic Attack-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Type 2 Diabetes Mellitus-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Papule-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Compression Fracture-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Paraesthesia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Candidiasis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Paranasal Cyst-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Meningeal Cyst-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pelvic Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Limb Fracture-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pericardial Effusion-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Osteoarthritis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Perineurial Cyst-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Pharyngitis-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Periodontal Disease-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Squamous Cell Carcinoma-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Limb Fracture-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Stress-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis Streptococcal-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Xeroderma-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pleural Effusion-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Suicide Attempt-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pleural Effusion-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-Mild | 0.013 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sunburn-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia Bacterial-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Rash-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia Pseudomonas Aeruginosa-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swelling Face-non-SAE-Sev | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pollakiuria-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pollakiuria-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swollen Tongue-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Polycystic Ovaries-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Complication-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Synovial Cyst-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Haemorrhage-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper-Airway Cough Syndrome-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Swelling-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tachycardia-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Nausea-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Upper Respiratory Tract Inf.-non-SAE-Mild | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Pain-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tachycardia-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Pain-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urethritis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Proctalgia-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendon Disorder-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Productive Cough-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Protein Urine Present-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendonitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus-non-SAE-Mild | 0.010 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Upper Respiratory Tract Inf-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendonitis-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus Allergic-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urticaria-non-SAE-Mild | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus Generalised-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Testicular Microlithiasis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Hypertension-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Hypertension-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Testicular Pain-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Vascular Disorder-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Uterine Polyp-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Puncture Site Pain-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thermal Burn-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Puncture Site Pain-non-SAE-Mod | 0.003 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vision Blurred-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Purpura Senile-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thinking Abnormal-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyogenic Granuloma-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vaginal Prolapse-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyrexia-non-SAE-Mild | 0.008 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thrombocytopenia-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyrexia-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wrist Fracture-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyuria-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tibia Fracture-non-SAE-Sev | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rales-non-SAE-Mod | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Varicose Vein-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rash-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tinea Cruris-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rash Generalised-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin B12 Deficiency-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rectal Polyp-non-SAE-Mod | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tinea Infection-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Red Blood Cells Urine Positive-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vasomotor Rhinitis-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-Mild | 0 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Abscess-non-SAE-Mild | 0.002 Number of AEs per infusion |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-Mod | 0 Number of AEs per infusion |
Secondary
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).
Categories presented as Preferred Term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe) Preferred terms abbreviated: ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease Other abbreviations: Inc. - Increased Dis. - Disease
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pain-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Mild | 0.317 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Distension-non-SAE-Mild | 0.095 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Hernia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Mass-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Mod | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Severe | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain Upper-non-SAE-Mild | 0.127 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Tenderness-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abnormal Loss of Weight-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acarodermatitis-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acarodermatitis-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acne-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acne-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Actinic Keratosis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Actinic Keratosis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Activities of Daily Living Impaired-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Sinusitis-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Sinusitis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Stress Disorder-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Adhesiolysis-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Age-Related Macular Degeneration-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Agitation-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aldolase Increased-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anaphylactic Reaction-non-SAE-Sev | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Animal Bite-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Animal Scratch-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anxiety-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anxiety-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Calcification-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Stenosis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Stenosis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Valve Incompetence-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Valve Incompetence-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aphthous Stomatitis-non-SAE-Mild | 0.079 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aphthous Stomatitis-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Appendicitis-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Application Site Erythema-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arteritis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthralgia-non-SAE-Mild | 0.127 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthralgia-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthropod Bite-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthenia-non-SAE-Mild | 0.111 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthenia-non-SAE-Mod | 0.143 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthma-non-SAE-Mild | 0.190 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthma-non-SAE-Mod | 0.317 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ataxia-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atelectasis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atrial Fibrillation-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atrial Fibrillation-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | ADHD-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Sev | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Basal Cell Carcinoma-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Basal Cell Carcinoma-non-SAE-Mod | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blepharochalasis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blister-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Bicarbonate Decreased-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatine Phosphokinase Inc.-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatine Phosphokinase Inc.-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatinine Increased-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Glucose Increased-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Urea Increased-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Urine Present-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Body Tinea-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bone Pain-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Breast Calcifications-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Breast Dysplasia-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchiolitis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchitis-non-SAE-Mild | 0.175 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchitis-non-SAE-Mod | 0.175 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Burns Second Degree-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bursitis-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Candidiasis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiac Failure Congestive-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiac Murmur-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomegaly-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomegaly-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomyopathy-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cataract-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cataract-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis Of Male Ext Genital Organ-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cerebral Small Vessel Ischaemic Dis.-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cerumen Impaction-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cervical Spinal Stenosis-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chapped Lips-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cheilitis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Discomfort-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Pain-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Pain-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chills-non-SAE-Mild | 0.206 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chills-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cholelithiasis-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chondromalacia-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chromaturia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chronic Sinusitis-non-SAE-Mild | 0.079 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chronic Sinusitis-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctival Haemorrhage-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctival Hyperaemia-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Allergic-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Allergic-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Infective-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Constipation-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Constipation-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Contusion-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Convulsion-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Convulsion-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspnoea-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Allergic-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysuria-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cough-non-SAE-Mild | 0.175 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysuria-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Atopic-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Infection-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cystocele-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Infection-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Contact-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pain-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Coombs Test Positive-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pruritus-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Contact-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ecchymosis-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Decreased Appetite-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ecchymosis-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Psoriasiform-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eczema-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cough-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eczema-non-SAE-Mod | 0.079 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Device Breakage-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Empty Sella Syndrome-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Decreased Appetite-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Epilepsy-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Device Failure-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Epistaxis-non-SAE-Mild | 0.175 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Costochondritis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Erythema-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Diarrhoea-non-SAE-Mild | 0.270 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eschar-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dehydration-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Excoriation-non-SAE-Mild | 0.127 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Diarrhoea-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Excoriation-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cryptosporidiosis Infection-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Haemorrhage-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dizziness-non-SAE-Mild | 0.159 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Infection-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dehydration-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Pain-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dizziness-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Swelling-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Coombs Direct Test Positive-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eyelid Ptosis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Drug Eruption-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Facial Bones Fracture-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dental Caries-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Facial Pain-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Drug Hypersensitivity-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fall-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cyst-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fall-non-SAE-Sev | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Eye-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Mod | 0.095 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Depression-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Eye-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Femur Fracture-SAE-Sev | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Costochondritis-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fibromyalgia-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Mouth-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Flatulence-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Depression-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Flushing-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Skin-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Folliculitis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cyst-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Food Poisoning-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysmenorrhoea-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Food Poisoning-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermal Cyst-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Foot Fracture-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspepsia-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Free Haemoglobin Present-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Corneal Abrasion-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Free Haemoglobin Present-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysplastic Naevus-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Frequent Bowel Movements-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fungal Infection-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspnoea-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fungal Skin Infection-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cystitis-non-SAE-Mild | 0.016 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Convulsion-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fungal Skin Infection-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Coombs Direct Test Positive-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Coombs Test Positive-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Corneal Abrasion-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Costochondritis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Costochondritis-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cough-non-SAE-Mild | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cough-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cryptosporidiosis Infection-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cyst-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cyst-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cystitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cystocele-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Decreased Appetite-non-SAE-Mild | 0.157 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Decreased Appetite-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dehydration-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dehydration-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dental Caries-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Depression-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Depression-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermal Cyst-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Allergic-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Atopic-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Contact-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Contact-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dermatitis Psoriasiform-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Device Breakage-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Device Failure-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Diarrhoea-non-SAE-Mild | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Diarrhoea-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dizziness-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dizziness-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Drug Eruption-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Drug Hypersensitivity-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Eye-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Eye-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Mouth-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dry Skin-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysmenorrhoea-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspepsia-non-SAE-Mild | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysplastic Naevus-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspnoea-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dyspnoea-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysuria-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Dysuria-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Infection-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Infection-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pain-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pruritus-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ecchymosis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ecchymosis-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eczema-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eczema-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Empty Sella Syndrome-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Epilepsy-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Epistaxis-non-SAE-Mild | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Erythema-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eschar-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Excoriation-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Excoriation-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Haemorrhage-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Infection-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Pain-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eye Swelling-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Eyelid Ptosis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Facial Bones Fracture-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Facial Pain-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fall-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Mild | 0.294 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Mod | 0.157 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fatigue-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Femur Fracture-SAE-Sev | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fibromyalgia-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Flatulence-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Flushing-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Folliculitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Food Poisoning-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Food Poisoning-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Foot Fracture-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Free Haemoglobin Present-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Free Haemoglobin Present-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Frequent Bowel Movements-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fungal Infection-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ear Pain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Fall-non-SAE-Sev | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blister-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cerebral Small Vessel Ischaemic Dis.-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Distension-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Bicarbonate Decreased-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Hernia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Constipation-non-SAE-Mild | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Mass-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatine Phosphokinase Inc.-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Mild | 0.078 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cerumen Impaction-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatine Phosphokinase Inc.-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain-non-SAE-Severe | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Pain Upper-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Creatinine Increased-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abdominal Tenderness-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cervical Spinal Stenosis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Abnormal Loss of Weight-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Glucose Increased-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acarodermatitis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Allergic-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acarodermatitis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Urea Increased-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acne-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chapped Lips-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acne-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blood Urine Present-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Actinic Keratosis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Actinic Keratosis-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Body Tinea-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Activities of Daily Living Impaired-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cheilitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Sinusitis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bone Pain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Sinusitis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Contusion-non-SAE-Mild | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Acute Stress Disorder-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Breast Calcifications-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Adhesiolysis-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Discomfort-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Age-Related Macular Degeneration-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Breast Dysplasia-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Agitation-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chronic Sinusitis-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aldolase Increased-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchiolitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anaphylactic Reaction-non-SAE-Sev | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Pain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Animal Bite-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchitis-non-SAE-Mild | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Animal Scratch-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Allergic-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anxiety-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bronchitis-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Anxiety-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chest Pain-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Calcification-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Burns Second Degree-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Stenosis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chronic Sinusitis-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Stenosis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Bursitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Valve Incompetence-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chills-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aortic Valve Incompetence-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Candidiasis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aphthous Stomatitis-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Constipation-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Aphthous Stomatitis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiac Failure Congestive-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Appendicitis-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chills-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Application Site Erythema-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiac Murmur-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arteritis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctival Haemorrhage-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthralgia-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomegaly-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthralgia-non-SAE-Mod | 0.118 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cholelithiasis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Arthropod Bite-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomegaly-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthenia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis Infective-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthenia-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cardiomyopathy-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthma-non-SAE-Mild | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chondromalacia-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Asthma-non-SAE-Mod | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cataract-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Ataxia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctival Hyperaemia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atelectasis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cataract-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atrial Fibrillation-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Chromaturia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Atrial Fibrillation-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | ADHD-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Convulsion-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Back Pain-non-SAE-Sev | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Basal Cell Carcinoma-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Conjunctivitis-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Basal Cell Carcinoma-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Cellulitis Of Male Ext Genital Organ-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Blepharochalasis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | COPD-non-SAE-Mod | 0 Number of AEs per participant |
Secondary
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).
Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Discomfort-non-SAE-Mild | 0.127 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemolysis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Erythema-non-SAE-Mild | 0.349 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hand Fracture-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Erythema-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemorrhoids-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Induration-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Mass-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemorrhoids-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Oedema-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Headache-non-SAE-Mild | 0.651 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pain-non-SAE-Mild | 1.238 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastritis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pain-non-SAE-Mod | 0.095 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Headache-non-SAE-Mod | 0.095 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pruritus-non-SAE-Mild | 0.492 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Swelling-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Heart Rate Irregular-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Swelling-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenitis-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Injection Site Pain-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Herpes Zoster-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Insomnia-non-SAE-Mild | 0.079 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Genital Herpes-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Insomnia-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hiatus Hernia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Intervertebral Disc Degeneration-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Iron Deficiency Anaemia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Genital Herpes-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Irritable Bowel Syndrome-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypercholesterolaemia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Jejunal Stenosis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypercapnia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Dislocation-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Swelling-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypersensitivity-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Laceration-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gingival Erosion-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Ligament Sprain-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Ligament Sprain-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Limb Discomfort-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-non-SAE-Mod | 0.095 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Liver Function Test Abnormal-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gingivitis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Local Swelling-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Localised Infection-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hydrocele-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Loss Of Consciousness-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypoaesthesia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lyme Disease-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Impetigo-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymph Gland Infection-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Glaucoma-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenitis Bacterial-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypokalaemia-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenopathy-non-SAE-Mild | 0.079 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Salmonella-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphopenia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypothyroidism-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Malaise-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Glycosuria-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Medical Device Pain-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypothyroidism-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Memory Impairment-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Spasms-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Meniscus Injury-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gout-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Menstrual Disorder-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Incision Site Pain-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mental Status Changes-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Viral-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Micturition Urgency-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Increased Upper Airway Secretion-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Middle Ear Effusion-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematochezia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Inflammation Of Wound-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Mod | 0.079 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Injury-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Sev | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza-non-SAE-Mod | 0.095 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mitral Valve Incompetence-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematospermia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Molluscum Contagiosum-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza Like Illness-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mouth Ulceration-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Viral-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mucosal Inflammation-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza Like Illness-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Contractions Involuntary-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Strain-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematuria-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscular Weakness-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Abscess-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscular Weakness-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastric Stenosis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Musculoskeletal Pain-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Bruising-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Musculoskeletal Pain-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemoglobin Decreased-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Myalgia-non-SAE-Mild | 0.397 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Discolouration-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Myalgia-non-SAE-Mod | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrointestinal Viral Infection-non-SAE-Mild | 0.016 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Myalgia-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hand Fracture-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hydrocele-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Dislocation-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Injury-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenitis-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Contractions Involuntary-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Spasms-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastric Stenosis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastritis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Salmonella-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Viral-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastroenteritis Viral-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrointestinal Viral Infection-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gastrooesophageal Reflux Disease-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Genital Herpes-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Genital Herpes-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gingival Erosion-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gingivitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Glaucoma-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Glycosuria-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Gout-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematochezia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematospermia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haematuria-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemoglobin Decreased-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemolysis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemorrhoids-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Headache-non-SAE-Mild | 0.765 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Headache-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Heart Rate Irregular-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Herpes Zoster-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hiatus Hernia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypercapnia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypercholesterolaemia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypersensitivity-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypertension-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypoaesthesia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypokalaemia-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypothyroidism-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Hypothyroidism-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Impetigo-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Incision Site Pain-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Increased Upper Airway Secretion-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Inflammation Of Wound-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza-non-SAE-Mod | 0.078 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza Like Illness-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Influenza Like Illness-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Abscess-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Bruising-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Discolouration-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Discomfort-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Erythema-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Erythema-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Induration-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Mass-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Oedema-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pain-non-SAE-Mild | 0.333 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pain-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Pruritus-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Swelling-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Infusion Site Swelling-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Injection Site Pain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Insomnia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Insomnia-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Intervertebral Disc Degeneration-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Iron Deficiency Anaemia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Irritable Bowel Syndrome-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Jejunal Stenosis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Joint Swelling-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Laceration-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Ligament Sprain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Ligament Sprain-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Limb Discomfort-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Liver Function Test Abnormal-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Local Swelling-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Localised Infection-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Loss Of Consciousness-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lyme Disease-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymph Gland Infection-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenitis Bacterial-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphadenopathy-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Lymphopenia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Malaise-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Medical Device Pain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Memory Impairment-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Meniscus Injury-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Menstrual Disorder-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mental Status Changes-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Micturition Urgency-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Middle Ear Effusion-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Mod | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Migraine-non-SAE-Sev | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mitral Valve Incompetence-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Molluscum Contagiosum-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mouth Ulceration-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Mucosal Inflammation-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscle Strain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscular Weakness-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Muscular Weakness-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Musculoskeletal Pain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Musculoskeletal Pain-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Myalgia-non-SAE-Mild | 0.118 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Haemorrhoids-non-SAE-Mod | 0 Number of AEs per participant |
Secondary
Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).
Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Xeroderma-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasopharyngitis-non-SAE-Mild | 0.111 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Neutrophil Count Decreased-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Media-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain-non-SAE-Mild | 0.143 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain In Extremity-non-SAE-Sev | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Palpitations-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Perineurial Cyst-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Periodontal Disease-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia Bacterial-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pollakiuria-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rash-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scab-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Meningeal Cyst-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Osteoarthritis-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Rash-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Congestion-non-SAE-Mild | 0.175 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Congestion-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasopharyngitis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nausea-non-SAE-Mild | 0.619 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nausea-non-SAE-Mod | 0.111 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nephrolithiasis-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nerve Compression-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Ocular Hyperaemia-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oedema Peripheral-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oedema Peripheral-non-SAE-Mod | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Candidiasis-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Herpes-non-SAE-Mild | 0.111 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Pain-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Pain-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Orchitis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oropharyngeal Pain-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoarthritis-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoarthritis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteopenia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoporosis-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Externa-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Externa-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain In Extremity-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Panic Attack-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Papule-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Paraesthesia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Paranasal Cyst-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pelvic Pain-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pericardial Effusion-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis-non-SAE-Mild | 0.095 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis Streptococcal-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pleural Effusion-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pleural Effusion-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia Pseudomonas Aeruginosa-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pollakiuria-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Polycystic Ovaries-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Complication-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Haemorrhage-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Swelling-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Nausea-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Pain-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Pain-non-SAE-Mod | 0.143 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Proctalgia-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Productive Cough-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Protein Urine Present-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus Allergic-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus Generalised-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Hypertension-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Hypertension-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Vascular Disorder-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Puncture Site Pain-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Puncture Site Pain-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Purpura Senile-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyogenic Granuloma-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyrexia-non-SAE-Mild | 0.222 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyrexia-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyuria-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rales-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rash Generalised-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rectal Polyp-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Red Blood Cells Urine Positive-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Infection-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Infection-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Restless Legs Syndrome-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinitis-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinitis Perennial-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinorrhoea-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Right Atrial Dilatation-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rotator Cuff Syndrome-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scar-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scoliosis-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scratch-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scrotal Swelling-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Seborrhoeic Keratosis-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinus Congestion-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinus Headache-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinusitis-non-SAE-Mild | 0.540 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinusitis-non-SAE-Mod | 0.460 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Hyperpigmentation-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Lesion-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Mass-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sleep Apnoea Syndrome-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Slow Speech-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Solar Lentigo-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Somnolence-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Speech Disorder-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spermatocele-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Compression Fracture-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Squamous Cell Carcinoma-non-SAE-Mod | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Stress-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Suicide Attempt-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sunburn-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swelling Face-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swelling Face-non-SAE-Sev | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swollen Tongue-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Synovial Cyst-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tachycardia-non-SAE-Mild | 0.079 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tachycardia-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendon Disorder-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendonitis-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendonitis-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Testicular Microlithiasis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Testicular Pain-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thermal Burn-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thinking Abnormal-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thrombocytopenia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tibia Fracture-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tinea Cruris-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tinea Infection-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Abscess-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Abscess-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Fracture-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Infection-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Infection-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Toothache-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Toxicity To Various Agents-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tracheal Stenosis-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Transient Ischaemic Attack-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Traumatic Haematoma-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tricuspid Valve Incompetence-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Trigeminal Neuralgia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tympanic Membrane Scarring-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Type 2 Diabetes Mellitus-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Limb Fracture-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Limb Fracture-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-Mild | 0.254 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-Mod | 0.206 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper-Airway Cough Syndrome-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urethritis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urinary Tract Infection-non-SAE-Mild | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urinary Tract Infection-non-SAE-Mod | 0.095 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urticaria-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Uterine Polyp-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vaginal Prolapse-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vaginitis Bacterial-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Varicose Vein-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vasomotor Rhinitis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vein Pain-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Ventricular Hypokinesia-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vessel Puncture Site Bruise-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Infection-non-SAE-Mild | 0.048 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Infection-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Pharyngitis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Pharyngitis-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Upper Respiratory Tract Inf.-non-SAE-Mild | 0.460 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Upper Respiratory Tract Inf-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vision Blurred-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin B12 Deficiency-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Decreased-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Deficiency-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Deficiency-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vomiting-non-SAE-Mild | 0.206 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vomiting-non-SAE-Mod | 0.063 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvar Dysplasia-non-SAE-Mild | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Candidiasis-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-Mod | 0.032 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wheezing-non-SAE-Mod | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-Mild | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-Sev | 0.016 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wound-non-SAE-Mild | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wrist Fracture-non-SAE-Mod | 0 Number of AEs per participant |
| All Participants Treated With IGSC, 10% and rHuPH20 | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Discomfort-non-SAE-Mild | 0.016 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scar-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Discomfort-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Toxicity To Various Agents-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nerve Compression-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scoliosis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Neutrophil Count Decreased-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Ventricular Hypokinesia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Media-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scratch-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tracheal Stenosis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain In Extremity-non-SAE-Sev | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scrotal Swelling-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Perineurial Cyst-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Seborrhoeic Keratosis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Transient Ischaemic Attack-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pollakiuria-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinus Congestion-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pollakiuria-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vessel Puncture Site Bruise-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rash-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rotator Cuff Syndrome-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinus Headache-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Scab-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Traumatic Haematoma-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Meningeal Cyst-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinusitis-non-SAE-Mild | 0.059 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Pharyngitis-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Deficiency-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Candidiasis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sinusitis-non-SAE-Mod | 0.255 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Xeroderma-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tricuspid Valve Incompetence-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Congestion-non-SAE-Mild | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Hyperpigmentation-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasal Congestion-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasopharyngitis-non-SAE-Mild | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Infection-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nasopharyngitis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Lesion-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nausea-non-SAE-Mild | 0.333 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Trigeminal Neuralgia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nausea-non-SAE-Mod | 0.157 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Skin Mass-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Nephrolithiasis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sleep Apnoea Syndrome-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Ocular Hyperaemia-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tympanic Membrane Scarring-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oedema Peripheral-non-SAE-Mild | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Slow Speech-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oedema Peripheral-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Infection-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Candidiasis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Solar Lentigo-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Herpes-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Type 2 Diabetes Mellitus-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Pain-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Somnolence-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oral Pain-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vomiting-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Orchitis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Speech Disorder-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Oropharyngeal Pain-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Limb Fracture-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoarthritis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spermatocele-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoarthritis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Pharyngitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteopenia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Compression Fracture-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Osteoporosis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Spinal Osteoarthritis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Externa-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Limb Fracture-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Otitis Externa-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Squamous Cell Carcinoma-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pain In Extremity-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Palpitations-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wheezing-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Panic Attack-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Stress-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Papule-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-Mild | 0.157 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Paraesthesia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Suicide Attempt-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Paranasal Cyst-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Rash-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pelvic Pain-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Sunburn-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pericardial Effusion-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Periodontal Disease-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper Respiratory Tract Infection-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swelling Face-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vomiting-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pharyngitis Streptococcal-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swelling Face-non-SAE-Sev | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pleural Effusion-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Upper-Airway Cough Syndrome-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pleural Effusion-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Swollen Tongue-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia Bacterial-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Upper Respiratory Tract Inf.-non-SAE-Mild | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pneumonia Pseudomonas Aeruginosa-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Synovial Cyst-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urethritis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Polycystic Ovaries-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tachycardia-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Complication-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wrist Fracture-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Haemorrhage-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tachycardia-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Post Procedural Swelling-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urinary Tract Infection-non-SAE-Mild | 0.078 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Nausea-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendon Disorder-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Pain-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Viral Upper Respiratory Tract Inf-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Procedural Pain-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendonitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Proctalgia-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urinary Tract Infection-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Productive Cough-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tendonitis-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Protein Urine Present-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvar Dysplasia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus-non-SAE-Mild | 0.118 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Testicular Microlithiasis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Urticaria-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus Allergic-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Testicular Pain-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pruritus Generalised-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vision Blurred-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Hypertension-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thermal Burn-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Hypertension-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Uterine Polyp-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pulmonary Vascular Disorder-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thinking Abnormal-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Puncture Site Pain-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wisdom Teeth Removal-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Puncture Site Pain-non-SAE-Mod | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Thrombocytopenia-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Purpura Senile-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vaginal Prolapse-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyogenic Granuloma-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tibia Fracture-non-SAE-Sev | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyrexia-non-SAE-Mild | 0.098 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin B12 Deficiency-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyrexia-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tinea Cruris-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Pyuria-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vaginitis Bacterial-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rales-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tinea Infection-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rash Generalised-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vulvovaginal Mycotic Infection-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rectal Polyp-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Abscess-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Red Blood Cells Urine Positive-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Varicose Vein-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Abscess-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Congestion-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Decreased-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Infection-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Fracture-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Respiratory Tract Infection-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vasomotor Rhinitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Restless Legs Syndrome-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Infection-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinitis-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Wound-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinitis Perennial-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Tooth Infection-non-SAE-Mod | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Rhinorrhoea-non-SAE-Mild | 0.039 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vein Pain-non-SAE-Mild | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Right Atrial Dilatation-non-SAE-Mild | 0 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Toothache-non-SAE-Mod | 0.020 Number of AEs per participant |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Vitamin D Deficiency-non-SAE-Mild | 0 Number of AEs per participant |
Secondary
The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs
Separated into age groups as described below and into related (related to either study drug) and not related (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution (IGSC), 10% and recombinant human hyaluronidase (rHuPH20).
Time frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants Treated With IGSC, 10% and rHuPH20 | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 2 to <12 years - not related | 0.0000 SAEs/year |
| All Participants Treated With IGSC, 10% and rHuPH20 | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 2 to <12 years - related | 0.0000 SAEs/year |
| All Participants Treated With IGSC, 10% and rHuPH20 | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 12 to <16 years - not related | 0.0768 SAEs/year |
| All Participants Treated With IGSC, 10% and rHuPH20 | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 12 to <16 years - related | 0.0000 SAEs/year |
| All Participants Treated With IGSC, 10% and rHuPH20 | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 16 to <65 years - not related | 0.0950 SAEs/year |
| All Participants Treated With IGSC, 10% and rHuPH20 | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 16 to <65 years - related | 0.0000 SAEs/year |
| All Participants Treated With IGSC, 10% and rHuPH20 | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 65 years and older- not related | 0.5737 SAEs/year |
| All Participants Treated With IGSC, 10% and rHuPH20 | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 65 years and older- related | 0.0000 SAEs/year |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 65 years and older- related | 0.0000 SAEs/year |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 2 to <12 years - not related | 0.0000 SAEs/year |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 16 to <65 years - not related | 0.0449 SAEs/year |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 2 to <12 years - related | 0.0000 SAEs/year |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 65 years and older- not related | 0.4728 SAEs/year |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 12 to <16 years - not related | 0.0000 SAEs/year |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 16 to <65 years - related | 0.0000 SAEs/year |
| Safety Follow-up - IGSC, 10% or IGIV, 10% Only | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Participants aged 12 to <16 years - related | 0.0000 SAEs/year |