Primary Immunodeficiency Diseases (PID)
Conditions
Brief summary
The purpose of the study is to develop a subcutaneous treatment option for participants with Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.
Interventions
BIOLOGICALRecombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)
Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (subcutaneous \[SC\] infusions) as bioavailability/exposure for intravenous (IV) treatment was already obtained in Study 160601. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up).
Sponsors
Baxalta now part of Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is 2 years or older at the time of screening * Written informed consent obtained from either the participant or the participant's legally acceptable representative prior to any study-related procedures and study product administration * Participant has been diagnosed with a PID disorder requiring antibody replacement as defined by WHO criteria * Participant has completed or is about to complete Baxter Clinical Study Protocol No. 160601 or has been receiving a regular IGIV-treatment at mean intervals of 21 ± 3 days or 28 ± 3 days, or SC at mean intervals of 5 to 16 days, over a period of at least 3 months prior to enrollment at a minimum dose of 300 mg/kg BW/4 weeks * Participant has a serum trough level of IgG \> 4.5 g/L at the last documented determination * If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study * Participant is willing and able to comply with the requirements of the protocol
Exclusion criteria
* Participant has a known history of or is positive at enrollment or screening for one or more of the following: Hepatitis B surface antigen (HbsAg), polymerase chain reaction (PCR) for Hepatitis C Virus (HCV), PCR for Human immunodeficiency virus (HIV) Type 1/2 * Participant has levels of alanine aminotransferase (ALT) or aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory * Participant has persistent severe neutropenia (defined as an absolute neutrophil count \[ANC\] \<= 500/mm3) * Participant has creatinine clearance (CLcr) values, calculated according to the formula below, which are \< 60% of normal for age and gender for males: CLcr = \[(140 - Age(years)) \* (body weight (kg))\] / \[72 \* (serum creatinine (mg/dL))\] for females: CLcr = \[(140 - Age(years)) \* (body weight(kg)) \* 0.85\] / \[72 \* (serum creatinine (mg/dL))\] * Participant has been diagnosed with, or has a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within the last 12 months prior to enrollment; participants treated with immunosuppressive chemotherapeutic agents during this period are excluded * Participant has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months * Participant has abnormal protein loss (protein losing enteropathy, nephrotic syndrome) * Participant has anemia that would preclude phlebotomy for laboratory studies * Participant has received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to enrollment * Participant has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin, and/or ISG infusions * Participant has immunoglobulin A (IgA) deficiency and known anti IgA antibodies * Participant is on preventative (prophylactic) antibiotics and cannot stop antibiotics at the time of enrollment * Participant has active infection who started on antibiotic therapy for the treatment of infection within 7 days prior to screening * Participant has a bleeding disorder or is on anti-coagulation therapy that results in a platelet count less than 20,000/μL or International Normalized Ration (INR) \> 2X control, or who, in the opinion of the investigator would be at significant risk of increased bleeding or bruising as a result of SC therapy * Participant has total protein \> 9 g/dL and participants with myeloma, macroglobulinemia (IgM) and paraproteinemia * Participant has a known allergy to hyaluronidase * If female, participant is pregnant or lactating at the time of study enrollment * Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study; exception: Baxter Study No. 160601 * Severe dermatitis that would preclude adequate sites for safe product administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validated Acute Serious Bacterial Infection (VASBI) Rate | Throughout the study period (17 months) | Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years | IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit | Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage. |
| Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf. | Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20. Expressed as a percentage. This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B): Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies). |
| Annual Rate of All Infections Per Participant | Throughout the study period (17 months) | Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint. |
| Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit. | Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up |
| Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit | Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4) |
| Antibody Levels to Tetanus (Clostridium Tetani Toxoid) | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 |
| Antibody Levels to Haemophilus Influenzae | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 |
| Antibody Levels to Measles | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 |
| Antibody Levels to Hepatitis B | IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit | Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20 |
| IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion | Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older |
| IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval). |
| IgG Clearance (CL) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC. |
| IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older |
| IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase |
| Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older |
| Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older |
| Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval). |
| Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC. |
| Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase |
| Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older |
| Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older |
| H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older |
| Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older |
| H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval). |
| H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC. |
| H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older |
| H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion. | Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase. |
| Rate of Days Off School or Work | Monthly, for up to 17 months | Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365\*400+100-3)/(400\*12)= 30.436875 days. |
| Rate of Days on Antibiotics | Monthly, for up to 17 months | Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365\*400+100-3)/(400\*12)= 30.436875 days. |
| Rate of Acute Physician Visits | Monthly, for up to 17 months | Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365\*400+100-3)/(400\*12)= 30.436875 days. |
| Rate of Days in Hospital | Monthly, for up to 17 months | Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365\*400+100-3)/(400\*12)= 30.436875 days. |
| Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | Throughout the study period (17 months) | Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion. |
| Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | Throughout the study period (17 months) | Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions |
| Rate of Temporally Associated AEs Per Infusion | During infusion or within 72 hours of completion of infusion | Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion (temporally associated) |
| Percentage of Participants Reporting ≥1 Temporally Associated AEs | During infusion or within 72 hours of completion of infusion | Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated) |
| Percentage of Infusions Resulting in ≥1 Temporally Associated AEs | During infusion or within 72 hours of completion of infusion | Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated) |
| Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | During infusion or within 72 hours of completion of infusion | Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated) |
| Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion | During infusion or within 72 hours of completion of infusion | Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated) |
| Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site | During infusion or within 60 minutes of completion of the infusion | Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site. An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion. |
| Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion | During infusion or within 72 hours of completion of infusion | Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion |
| Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | During infusion or within 72 hours of completion of infusion | Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion |
| Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | During infusion or within 72 hours of completion of infusion | Percentage of IV and SC (with recombinant human hyaluronidase \[rHuPH20\]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion |
| Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study | At any time during the study | Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study |
| Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion | During infusion or within 72 hours of completion of infusion | Percentage of participants With ≥1 local AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion |
| Percentage of Participants With ≥1 Local AE At Any Time During the Study | During infusion or within 72 hours of completion of infusion | Percentage of participants With ≥1 local AE (including and excluding infections) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up at any time during the study |
| Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant | Throughout the study period (17 months) | Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous \[IGIV\], 10% or recombinant human hyaluronidase \[rHuPH20\]), that occur at any time during the study divided by the total number of participants |
| Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion | Throughout the study period (17 months) | Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous \[IGIV\], 10% or recombinant human hyaluronidase \[rHuPH20\]), that occur at any time during the study divided by the total number of infusions |
| Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment) | Throughout the study period (17 months) | Frequency of dose corrections based on immune globulin G (IgG) trough levels \<4.5 g/L IgG, if any, for intravenous (IV) (Epoch 1) and subcutaneous with recombinant human hyaluronidase (SC/rHuPH20) after ramp-up (Epoch 2) administration of immune globulin intravenous (IGIV), 10% Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set. |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe |
| Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe |
| Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years | PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion | Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage. |
| Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs | Throughout the study period (17 months) | Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, \[administered via intravenous (IV) or subcutaneous (SC) route\], recombinant human hyaluronidase (rHuPH20) or both. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed. |
| Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment) | Throughout the study period (17 months) | Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up. Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed. |
| Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion | Throughout the study period (17 months) | Temporally associated defined as during infusion or within 72 hours of completion of infusion. Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous \[IGIV\], 10% or recombinant human hyaluronidase \[rHuPH20\]). Expressed as a percentage. |
| Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) | Throughout the study period (17 months) | — |
| Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) | Throughout the study period (17 months) | — |
| Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis | Throughout the study period (17 months) | Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis |
| Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis | Throughout the study period (17 months) | Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis |
| Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Throughout the study period (17 months) | Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used: Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment was conducted 14 clinical sites in the United States and 1 clinical site in Canada.
Pre-assignment details
89 participants who enrolled were screened. Of these, 2 withdrew before treatment (both were screen failures)
Participants by arm
| Arm | Count |
|---|---|
| 2 to <12 Years The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to \<12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children. | 14 |
| 12 Years and Older EPOCH 1: Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of Subcutaneous (SC) infusions Recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV). Participants who previously participated in Study 160601 entered this study at Epoch 2. PK data collected during IV treatment in Study 160601 were used for comparison with PK data from SC treatment during this study (160603). EPOCH 2: (ramp-up and After ramp-up). Participants were treated SC with GAMMAGARD LIQUID/KIOVIG at 108% of IV dose from Epoch 1 or Study 160601. 108% was derived from PK data from Study 160602. Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment (ramp-up), to allow participants to adjust to increasing volume administered SC. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV. | 73 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Between Epoch 1 (IV) and Epoch 2 Ramp-up | Withdrawal by Subject | 0 | 1 |
| Epoch 1 (IV Treatment) | Participant missed 2 consecutive doses | 0 | 2 |
| Epoch 1 (IV Treatment) | Withdrawal by Subject | 1 | 0 |
| Epoch 2 After Ramp-up (SC/rHuPH20) | Adverse Event | 1 | 4 |
| Epoch 2 After Ramp-up (SC/rHuPH20) | Lost to Follow-up | 0 | 1 |
| Epoch 2 After Ramp-up (SC/rHuPH20) | Subject Felt Increased Infections on SC | 0 | 1 |
| Epoch 2 After Ramp-up (SC/rHuPH20) | Switched to safety follow-up | 0 | 3 |
| Epoch 2 After Ramp-up (SC/rHuPH20) | Withdrawal by Subject | 2 | 1 |
| Epoch 2 Ramp-up (Ramp-up) | Adverse Event | 1 | 0 |
| Epoch 2 Ramp-up (Ramp-up) | Geographic Factor | 1 | 0 |
Baseline characteristics
| Characteristic | 2 to <12 Years | 12 Years and Older | Total |
|---|---|---|---|
| Age, Continuous | 8.0 years | 44.0 years | 35.0 years |
| Region of Enrollment Canada | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 14 Participants | 72 Participants | 86 Participants |
| Sex: Female, Male Female | 6 Participants | 37 Participants | 43 Participants |
| Sex: Female, Male Male | 8 Participants | 36 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 67 / 87 | 81 / 83 |
| serious Total, serious adverse events | 3 / 87 | 12 / 83 |
Outcome results
Primary
Validated Acute Serious Bacterial Infection (VASBI) Rate
Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant.
Time frame: Throughout the study period (17 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Validated Acute Serious Bacterial Infection (VASBI) Rate | 0.025 Estimated infections/year |
Comparison: For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, onlyp-value: <0.0001Poisson
Secondary
Annual Rate of All Infections Per Participant
Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint.
Time frame: Throughout the study period (17 months)
Population: Full Analysis Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Annual Rate of All Infections Per Participant | 4.51 Estimated infections/year |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Annual Rate of All Infections Per Participant | 2.97 Estimated infections/year |
Secondary
Antibody Levels to Haemophilus Influenzae
Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20
Time frame: IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit
Population: Participants in Full Analysis Data Set with available specific antibody test results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Antibody Levels to Haemophilus Influenzae | Influenza antibody end of IV treatment (N=7,24) | 2.11 μg/mL |
| Full Analysis Data Set (FADS) | Antibody Levels to Haemophilus Influenzae | Influenza antibody end of SC treatment (N=10,70) | 1.97 μg/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Antibody Levels to Haemophilus Influenzae | Influenza antibody end of IV treatment (N=7,24) | 2.36 μg/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Antibody Levels to Haemophilus Influenzae | Influenza antibody end of SC treatment (N=10,70) | 2.58 μg/mL |
Secondary
Antibody Levels to Hepatitis B
Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20
Time frame: IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit
Population: Participants in the Full Analysis Data Set with available specific antibody test results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Antibody Levels to Hepatitis B | Hepatitis B antibody end IV treatment (N=6,25) | 212.9 mIU/mL |
| Full Analysis Data Set (FADS) | Antibody Levels to Hepatitis B | Hepatitis B antibody end of SC treatment (N=10,70) | 242.2 mIU/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Antibody Levels to Hepatitis B | Hepatitis B antibody end of SC treatment (N=10,70) | 249.2 mIU/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Antibody Levels to Hepatitis B | Hepatitis B antibody end IV treatment (N=6,25) | 222.8 mIU/mL |
Secondary
Antibody Levels to Measles
Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20
Time frame: IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit
Population: Participants in the Full Analysis Data Set with available specific antibody test results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Antibody Levels to Measles | Measles antibody end of IV treatment (N=0,1) | NA Titer |
| Full Analysis Data Set (FADS) | Antibody Levels to Measles | Measles antibody end of SC treatment (N=10,70) | 768.0 Titer |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Antibody Levels to Measles | Measles antibody end of SC treatment (N=10,70) | 1024.0 Titer |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Antibody Levels to Measles | Measles antibody end of IV treatment (N=0,1) | 64.0 Titer |
Secondary
Antibody Levels to Tetanus (Clostridium Tetani Toxoid)
Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20
Time frame: IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit
Population: Participants in Full Analysis Data Set with available specific antibody test results
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Antibody Levels to Tetanus (Clostridium Tetani Toxoid) | End of IV treatment (N=7,25) | 2.230 IU/mL |
| Full Analysis Data Set (FADS) | Antibody Levels to Tetanus (Clostridium Tetani Toxoid) | End of SC/rHuPH20 treatment (N=10,70) | 2.580 IU/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Antibody Levels to Tetanus (Clostridium Tetani Toxoid) | End of IV treatment (N=7,25) | 2.320 IU/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Antibody Levels to Tetanus (Clostridium Tetani Toxoid) | End of SC/rHuPH20 treatment (N=10,70) | 2.525 IU/mL |
Secondary
Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years
Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.
Time frame: PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion
Population: Participants ≥ 12 years exposed to either or both study drugs with AUC measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years | 93.3 Percentage |
Secondary
Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20
Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20. Expressed as a percentage. This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B): Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies).
Time frame: PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf.
Population: Participants in the Full Analysis Data Set aged ≥ 12 years from the current study (160603) and prior Baxter study 160601 who received IGIV, 10% via SC administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | Participants in Stratum A (N=19) | 118.7 Percentage |
| Full Analysis Data Set (FADS) | Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | Participants in Stratum B (N=54) | 133.6 Percentage |
| Full Analysis Data Set (FADS) | Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20 | Total Participants (N=73) | 120.4 Percentage |
Secondary
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years
Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.
Time frame: IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit
Population: Participants aged 2 to \< 12 years exposed to either or both study drugs with available IgG trough level measurements
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years | 103.8 Percentage |
Secondary
Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment)
Frequency of dose corrections based on immune globulin G (IgG) trough levels \<4.5 g/L IgG, if any, for intravenous (IV) (Epoch 1) and subcutaneous with recombinant human hyaluronidase (SC/rHuPH20) after ramp-up (Epoch 2) administration of immune globulin intravenous (IGIV), 10% Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment) | 0.0 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment) | 0.0 Percentage of participants |
Secondary
H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | 22.4 μg*days/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | 22.5 μg*days/mL |
Secondary
H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older
Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC.
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older | 5.8 L/kg/day |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older | 6.4 L/kg/day |
Secondary
H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | 5.5 μg/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | 4.1 μg/mL |
Secondary
H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | 2.1 μg/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | 2.2 μg/mL |
Secondary
H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase.
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | 33.8 Days |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | 35.0 Days |
Secondary
IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | 93.9 g*days/L |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | 90.5 g*days/L |
Secondary
IgG Clearance (CL) for Participants Aged 12 Years and Older
Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC.
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | IgG Clearance (CL) for Participants Aged 12 Years and Older | 1.4 mL/kg/day |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | IgG Clearance (CL) for Participants Aged 12 Years and Older | 1.6 mL/kg/day |
Secondary
IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | 21.9 g/L |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | 15.5 g/L |
Secondary
IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | 10.1 g/L |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | 10.4 g/L |
Secondary
IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | 35.7 Days |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | 45.3 Days |
Secondary
Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion
Temporally associated defined as during infusion or within 72 hours of completion of infusion. Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous \[IGIV\], 10% or recombinant human hyaluronidase \[rHuPH20\]). Expressed as a percentage.
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion | Including Infections | 0.25 Percentage of AE |
| Full Analysis Data Set (FADS) | Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion | Excluding Infections | 0.25 Percentage of AE |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion | Including Infections | 0.22 Percentage of AE |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion | Excluding Infections | 0.18 Percentage of AE |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to 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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Breast Pain-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchitis-non-SAE, NR, Mild | 4 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Candidiasis-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Candidiasis-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | COPD-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Hernia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Aspiration-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthenia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthma-non-SAE, NR, Mod | 8 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | ADHD-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Back Injury-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Back Pain-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | BP Systolic Increased-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bacterial Prostatitis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blister-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blepharitis-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Decreased-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Urea Increased-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Decreased-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Increased-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Body Fat Disorder-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Body Tinea-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Body Tinea-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bone Pain-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchal Hyperreactivity-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchitis-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Increased-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchitis-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chills-non-SAE, RIGIV, Mod | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchospasm-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Burn Infection-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Burning Sensation-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Burning Sensation-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Burning Sensation-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bursitis-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bursitis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cardiac Murmur-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cellulitis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cellulitis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cellulitis-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cerumen Impaction-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cervical Dysplasia-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cheilitis-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chest Pain-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chills-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chills-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | COPD-non-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chronic Sinusitis-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Concussion-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Confusional State-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Confusional State-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Constipation-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Contusion-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Contusion-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Contusion-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Coombs Test Positive-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Costochondritis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cough-non-SAE, NR, Mild | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cough-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chills-non-SAE, RIGIV, Mild | 6 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eye Pruritus-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ear Infection-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ear Pain-non-SAE, NR, Mild | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ear Pain-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ecchymosis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eczema-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eczema-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eczema-non-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eosinophil Count-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Epitaxis-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Epitaxis-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Feeling Abnormal-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Feeling Cold-non-SAE, RIGIV, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Flatulence-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Flatulence-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Food Poisoning-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Free Haemoglobin Present-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Free Haemoglobin Present-non-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cough-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cushingoid-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Discomfort-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Distension-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Lower-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Alopecia-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Animal Bite-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Antibody Test Positive-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Anxiety-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Tenderness-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Acarodermatitis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Acne-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Acute Sinusitis-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Acute Sinusitis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Adenoidal Hypertrophy-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Adnexa Uteri Cyst-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Adrenocortical Insufficiency Acute-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Allergic Respiratory Symptom-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Allergic Sinusitis-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Anxiety-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Aphthous Stomatitis-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Aphthous Stomatitis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arteriosclerosis Coronary Artery-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthralgia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthralgia-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthralgia-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthralgia-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthritis-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthropathy-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthropod Bite-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthropod Sting-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthropod Sting-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthenia-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthenia-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthma-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthma-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Back Injury-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Back Pain-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cystitis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eustachian Tube Dysfunction-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Excoriation-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Deafness Neurosensory-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Decreased Appetite-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Decreased Appetite-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Decreased Appetite-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dehydration-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dental Caries-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dental Caries-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Depressed Mood-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Depression-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermal Cyst-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Acneiform-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Contact-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Contact-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Infected-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Infected-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Infected-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Device Failure-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Device Failure-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea-non-SAE, NR, Mild | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea Infectious-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Extravasation Blood-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eye Irritation-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eye Swelling-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fall-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fall-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, RIGIV, Mild | 8 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diastolic Dysfunction-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Disaccharide Metabolism Disorder-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Disturbance in Attention-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diverticulitis-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dizziness-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dizziness-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dizziness-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dizziness-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Drug Eruption-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dry Eye-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dry Mouth-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dry Skin-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dysmenorrhoea-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspepsia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspepsia-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspepsia-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dysphagia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dysphagia-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspnoea-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspnoea-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspnoea-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dysuria-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ear Infection-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Alopecia-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Decreased-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Body Fat Disorder-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bone Pain-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dental Caries-non-SAE, NR, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Animal Bite-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bursitis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Candidiasis-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Antibody Test Positive-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chest Pain-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chills-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Depressed Mood-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Anxiety-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cough-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cough-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspnoea-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, NR, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Allergic Sinusitis-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Aspiration-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Depression-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Upper-non-SAE, Rboth, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthma-non-SAE, NR, Mod | 21 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, RIGIV, Mild | 8 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | ADHD-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Tenderness-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Back Injury-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermal Cyst-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Back Pain-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Back Pain-non-SAE, NR, Mod | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blepharitis-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Increased-non-SAE, RrHu, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | BP Systolic Increased-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dry Mouth-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blister-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Acarodermatitis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Decreased-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea Infectious-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Acne-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Increased-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Urea Increased-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Acute Sinusitis-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dysphagia-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Acute Sinusitis-non-SAE, NR, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Body Tinea-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Acneiform-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Body Tinea-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Adenoidal Hypertrophy-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Breast Pain-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diastolic Dysfunction-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchal Hyperreactivity-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchitis-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Adnexa Uteri Cyst-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchitis-non-SAE, NR, Mod | 8 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Contact-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Adrenocortical Insufficiency Acute-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dry Skin-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Allergic Respiratory Symptom-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchitis-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Contact-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bronchospasm-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Disaccharide Metabolism Disorder-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Burn Infection-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthropod Bite-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Burning Sensation-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Anxiety-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Burning Sensation-non-SAE, RIGIV, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Infected-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Burning Sensation-non-SAE, RrHu, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Aphthous Stomatitis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bursitis-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspnoea-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Candidiasis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Aphthous Stomatitis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cardiac Murmur-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Infected-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cellulitis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arteriosclerosis Coronary Artery-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cellulitis-non-SAE, NR, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Disturbance in Attention-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cellulitis-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthralgia-non-SAE, NR, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cerumen Impaction-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dermatitis Infected-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cervical Dysplasia-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthralgia-non-SAE, NR, Mod | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cheilitis-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dysmenorrhoea-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthralgia-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Bacterial Prostatitis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Device Failure-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chills-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthralgia-non-SAE, RIGIV, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chills-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | COPD-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diverticulitis-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | COPD-non-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthritis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chronic Sinusitis-non-SAE, NR, Mild | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Device Failure-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chronic Sinusitis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthropathy-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Concussion-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dysphagia-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Confusional State-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea-non-SAE, NR, Mild | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Confusional State-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthropod Sting-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dizziness-non-SAE, NR, Mild | 7 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Arthropod Sting-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Constipation-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthenia-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Contusion-non-SAE, NR, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea-non-SAE, NR, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Contusion-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthenia-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Contusion-non-SAE, RIGIV, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, RIGIV, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Coombs Test Positive-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthenia-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Costochondritis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cough-non-SAE, NR, Mild | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthma-non-SAE, NR, Mild | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspepsia-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Chills-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Asthma-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Free Haemoglobin Present-non-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ear Infection-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Diarrhoea-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ear Infection-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Back Injury-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ear Pain-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dizziness-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ear Pain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dysuria-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Ecchymosis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dizziness-non-SAE, RIGIV, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eczema-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eczema-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Extravasation Blood-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eczema-non-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, RIGIV, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eosinophil Count-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspepsia-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Epitaxis-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, RrHu, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eye Irritation-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, Rboth, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Feeling Abnormal-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eye Pruritus-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Feeling Cold-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Erythema-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Flatulence-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dizziness-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Flatulence-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eustachian Tube Dysfunction-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Food Poisoning-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Eye Swelling-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Free Haemoglobin Present-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Excoriation-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Epitaxis-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cystitis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspnoea-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Cushingoid-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Deafness Neurosensory-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fall-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Discomfort-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Decreased Appetite-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Distension-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Hernia-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Drug Eruption-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Decreased Appetite-non-SAE, RrHu, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fall-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain-non-SAE, Rboth, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Decreased Appetite-non-SAE, Rboth, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dyspepsia-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Abdominal Pain Lower-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dehydration-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Fatigue-non-SAE, NR, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dental Caries-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F) | Dry Eye-non-SAE, NR, Mod | 1 Number of AEs |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to 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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Localised Infection-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Spasms-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Spasms-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Localised Oedema-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Strain-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haematoma-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Strain-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Localised Oedema-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscular Weakness-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, RIGIV, Mild | 25 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lung Infection-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Grand Mal Convulsion-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Pain-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lung Infection-non-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Pain-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, RIGIV, Mod | 12 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Stiffness-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymph Gland Infection-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, NR, Mild | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gait Disturbance-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymph Node Pain-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, RIGIV, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymph Node Pain-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymph Node Palpable-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Heart Rate Increased-non-SAE, RIGIV, Mild | 4 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphadenitis-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Heat Rash-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Heat Stroke-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Herpes Simplex Ophthalmic-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Herpes Zoster-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hiatus Hernia-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gravitational Oedema-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hot Flush-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis Bacterial-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hyperaesthesia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypercholesterolaemia-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis Viral-non-SAE, NR, Mild | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hyperkeratosis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypertension-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis Viral-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypertension-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hearing Impaired-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypertension-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis Viral-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypertonia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haematoma-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypothyroidism-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastrointestinal Haemorrhage-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Idiopathic Urticaria-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Range of Motion Decreased-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Increased Upper Airway Secretion-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infected Bites-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Injection Site Erythema-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infected Bites-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Genital Herpes-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infection-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphadenopathy-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Influenza-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Sprain-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Influenza-non-SAE, NR, Mod | 4 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Genital Swelling-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Influenza Like Illness-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haematuria-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Goitre-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Sprain-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gout-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Groin Pain-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Discomfort-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Grand Mal Convulsion-non-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Discomfort-non-SAE, RrHu, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Swelling-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haemoglobin Abnormal-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphocyte Count Decreased-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Erythema-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Jugular Vein Distension-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Erythema-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphangitis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphoedema-non-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Extravasation-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Haematoma-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lethargy-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Haemorrhage-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haemorrhoids-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Hypersensitivity-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Hypersensitivity-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lethargy-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Mass-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Mass-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Groin Pain-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Ligament Injury-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, RrHu, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hand Fracture-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Memory Impairment-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Ligament Sprain-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, RrHu, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Effusion-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, Rboth, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Limb Injury-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pruritus-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, NR, Mild | 13 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lip Injury-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Groin Pain-non-SAE, RrHu, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Swelling-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, RIGIV, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lip Ulceration-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Swelling-non-SAE, Rboth, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Injury-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Warmth-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Molluscum Contagiosum-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Ingrowing Nail-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Local Swelling-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Mouth Ulceration-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Injury-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Insomnia-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Multiple Sclerosis Relapse-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Intervertebral Disc Protrusion-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Local Swelling-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Fatigue-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Effusion-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Injury-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Effusion-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Effusion-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Grand Mal Convulsion-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gravitational Oedema-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Groin Pain-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Groin Pain-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Groin Pain-non-SAE, RrHu, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haematoma-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gait Disturbance-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haematoma-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haematuria-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haemoglobin Abnormal-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Haemorrhoids-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hand Fracture-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, NR, Mild | 16 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, NR, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, RIGIV, Mild | 14 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, RIGIV, Mod | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, RIGIV, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, Rboth, Mild | 9 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-non-SAE, Rboth, Mod | 8 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Headache-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Injury-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Range of Motion Decreased-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Sprain-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Sprain-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Joint Swelling-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Jugular Vein Distension-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lethargy-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lethargy-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Ligament Injury-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Ligament Sprain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Limb Injury-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lip Injury-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lip Ulceration-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Local Swelling-non-SAE, RIGIV, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Local Swelling-non-SAE, Rboth, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Localised Infection-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Localised Oedema-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Localised Oedema-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lung Infection-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lung Infection-non-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymph Gland Infection-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymph Node Pain-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymph Node Pain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymph Node Palpable-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphadenitis-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis Bacterial-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis Viral-non-SAE, NR, Mild | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis Viral-non-SAE, NR, Mod | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis Viral-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastrointestinal Haemorrhage-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Genital Herpes-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Genital Swelling-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Goitre-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gout-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Grand Mal Convulsion-non-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphadenopathy-non-SAE, NR, Mild | 8 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphocyte Count Decreased-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphoedema-non-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Lymphangitis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, RrHu, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Malaise-non-SAE, RrHu, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Memory Impairment-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, RIGIV, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, RIGIV, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Migraine-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Molluscum Contagiosum-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Mouth Ulceration-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Multiple Sclerosis Relapse-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Fatigue-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Injury-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Spasms-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Spasms-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Strain-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscle Strain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Muscular Weakness-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Pain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Musculoskeletal Stiffness-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, NR, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, NR, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, RIGIV, Mild | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, RIGIV, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Myalgia-non-SAE, Rboth, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hearing Impaired-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Heart Rate Increased-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Heat Rash-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Heat Stroke-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Herpes Simplex Ophthalmic-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Herpes Zoster-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hiatus Hernia-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hot Flush-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hyperaesthesia-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypercholesterolaemia-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hyperkeratosis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypertension-non-SAE, NR, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypertension-non-SAE, RIGIV, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypertension-non-SAE, RIGIV, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypertonia-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Hypothyroidism-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Idiopathic Urticaria-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Increased Upper Airway Secretion-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infected Bites-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infected Bites-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infection-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Influenza-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Influenza-non-SAE, NR, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Influenza Like Illness-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Discomfort-non-SAE, RIGIV, Mild | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Discomfort-non-SAE, RrHu, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mild | 15 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mod | 8 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Erythema-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Erythema-non-SAE, RrHu, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mild | 20 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mod | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Extravasation-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Haematoma-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Haemorrhage-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Hypersensitivity-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Hypersensitivity-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Mass-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Mass-non-SAE, Rboth, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mild | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mod | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mild | 12 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mod | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, RrHu, Mild | 35 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, RrHu, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, Rboth, Mild | 19 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, Rboth, Mod | 16 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pain-non-SAE, Rboth, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pruritus-non-SAE, RIGIV, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pruritus-non-SAE, RrHu, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mild | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Swelling-non-SAE, RIGIV, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Swelling-non-SAE, Rboth, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Infusion Site Warmth-non-SAE, Rboth, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Ingrowing Nail-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Injection Site Erythema-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Injury-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Insomnia-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Intervertebral Disc Protrusion-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M) | Gastroenteritis-non-SAE, NR, Mod | 2 Number of AEs |
Secondary
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to 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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pharyngitis-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Pustular-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Pustular-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Papular-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Failure-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Rate Increased-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Tract Congestion-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Tract Infection Viral-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rhinitis Allergic-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rhinitis Allergic-non-SAE, NR, Mod | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rhinitis Allergic-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rhinorrhoea-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Road Traffic Accident-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Scleritis-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Scleritis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Scratch-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Seborrhoeic Dermatitis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sicca Syndrome-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinus Congestion-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinus Headache-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinusitis-non-SAE, NR, Mild | 6 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinusitis-non-SAE, NR, Mod | 13 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinusitis-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinusitis-non-SAE, RIGIV, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skeletal Injury-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skeletal Injury-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Hyperpigmentation-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Laceration-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Laceration-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Lesion-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Lesion-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Lesion-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Papilloma-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Spinal Osteoarthritis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Squamous Cell Carcinoma-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Status Epilepticus-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Suicidal Ideation-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sunburn-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Swelling-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Swelling-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Syncope-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tachycardia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tachycardia-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Therapy Cessation-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Thrombosis-non-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Thrombosis-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tinea Infection-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tongue Coated-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tonsillar Hypertrophy-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tonsillar Hypertrophy-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tooth Abscess-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tooth Abscess-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tooth Impacted-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tooth Infection-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Toothache-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tongue Injury-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tremor-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tricuspid Valve Incompetence-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tympanic Membrane Disorder-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tympanic Membrane Hyperaemia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Upper Airway Cough Syndrome-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mild | 7 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urinary Tract Infection-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urinary Tract Infection-non-SAE, NR, Mod | 5 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urine Analysis Abnormal-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urticaria-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urticaria-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urticaria-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Uterine Polyp-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vaginal Haemorrhage-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vascular Access Complication-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vertigo-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Diarrhoea-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Infection-non-SAE, NR, Mild | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Infection-non-SAE, NR, Mod | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Infection-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Congestion-non-SAE, NR, Mild | 4 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Congestion-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Congestion-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Discomfort-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Mucosal Discolouration-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Turbinate Hypertrophy-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasopharyngitis-non-SAE, NR, Mild | 4 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, NR, Mild | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, RIGIV, Mild | 7 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Neck Pain-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Night Sweats-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Night Sweats-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nodule-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema Genital-non-SAE, Rboth, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema Peripheral-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema Peripheral-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema Peripheral-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oesophagitis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Onychomycosis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Candidiasis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Fungal Infection-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Herpes-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Herpes-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Pain-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Pain-non-SAE, RrHu, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Osteoarthritis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Osteopenia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Osteopenia-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Osteoporosis-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Otitis Externa-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Otitis Externa-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Otitis Media-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, RIGIV, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, RIGIV, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, RIGIV, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Palpitations-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Papule-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Peptic Ulcer Haemorrhage-SAE, NR, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Periorbital Haematoma-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Peripheral Nerve Injury-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pertussis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Petit Mal Epilepsy-SAE, NR, Severe | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pharyngeal Erythema-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Wheezing-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pharyngitis-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pharyngitis Streptococcal-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pneumonia-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pneumonia-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pneumonia Bacterial-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Post Procedural Infection-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Post Procedural Infection-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Postictal Paralysis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Postoperative Wound Infection-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Procedural Pain-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Procedural Pain-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Productive Cough-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus-non-SAE, RIGIV, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus Generalized-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pseudomonas Infection-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Psoriasis-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, NR, Mild | 3 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, NR, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, RIGIV, Mild | 4 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, RIGIV, Mod | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rales-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rales-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash-non-SAE, NR, Mild | 2 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Erythematous-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Macro-Papular-non-SAE, Rboth, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vision Blurred-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mild | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, NR, Mild | 5 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, NR, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, RIGIV, Mild | 4 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, RIGIV, Mod | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, RIGIV, Severe | 1 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, Rboth, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vulvovaginal Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Weight Decreased-non-SAE, RrHu, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Weight Decreased-non-SAE, RrHu, Mod | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | WBC Count Decreased-non-SAE, RIGIV, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | White Blood Cells Urine Positive-non-SAE, NR, Mild | 0 Number of AEs |
| Full Analysis Data Set (FADS) | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | WBC Urine Positive-non-SAE, RIGIV Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | White Blood Cells Urine Positive-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Wheezing-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Macro-Papular-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Neck Pain-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Pustular-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pharyngitis-non-SAE, NR, Mild | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Pustular-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Night Sweats-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Papular-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, RIGIV, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Failure-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Night Sweats-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Rate Increased-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pharyngitis-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Tract Congestion-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nodule-non-SAE, Rboth, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, NR, Mild | 7 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Respiratory Tract Infection Viral-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pharyngitis Streptococcal-non-SAE, NR, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rhinitis Allergic-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema Genital-non-SAE, Rboth, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rhinitis Allergic-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, Rboth, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rhinitis Allergic-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema Peripheral-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rhinorrhoea-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pneumonia-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Road Traffic Accident-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema Peripheral-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Scleritis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vulvovaginal Pruritus-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Scleritis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oedema Peripheral-non-SAE, Rboth, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Scratch-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pneumonia-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Seborrhoeic Dermatitis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oesophagitis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sicca Syndrome-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rales-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinus Congestion-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Onychomycosis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinus Headache-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pneumonia Bacterial-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinusitis-non-SAE, NR, Mild | 25 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Candidiasis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinusitis-non-SAE, NR, Mod | 26 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, NR, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinusitis-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Fungal Infection-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sinusitis-non-SAE, RIGIV, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Post Procedural Infection-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skeletal Injury-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Herpes-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skeletal Injury-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rales-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Hyperpigmentation-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Herpes-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Laceration-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Post Procedural Infection-non-SAE, NR, Mod | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Laceration-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Pain-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Lesion-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | WBC Count Decreased-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Lesion-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oral Pain-non-SAE, RrHu, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Lesion-non-SAE, RIGIV, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Postictal Paralysis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Skin Papilloma-non-SAE, NR, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mild | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Spinal Osteoarthritis-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash-non-SAE, NR, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Squamous Cell Carcinoma-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Status Epilepticus-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Postoperative Wound Infection-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Suicidal Ideation-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Osteoarthritis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Sunburn-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, RIGIV, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Swelling-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Osteopenia-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Swelling-non-SAE, Rboth, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Procedural Pain-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Syncope-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Osteopenia-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tachycardia-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tachycardia-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Osteoporosis-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Therapy Cessation-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Procedural Pain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Thrombosis-non-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Otitis Externa-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Thrombosis-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Weight Decreased-non-SAE, RrHu, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tinea Infection-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Otitis Externa-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tongue Coated-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Productive Cough-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tonsillar Hypertrophy-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Otitis Media-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tonsillar Hypertrophy-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Rash Erythematous-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tooth Abscess-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, NR, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tooth Abscess-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tooth Impacted-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, RIGIV, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tooth Infection-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Toothache-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tongue Injury-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tremor-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | WBC Urine Positive-non-SAE, RIGIV Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tricuspid Valve Incompetence-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, RIGIV, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tympanic Membrane Disorder-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Tympanic Membrane Hyperaemia-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, Rboth, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Upper Airway Cough Syndrome-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mild | 34 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mod | 10 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urinary Tract Infection-non-SAE, NR, Mild | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urinary Tract Infection-non-SAE, NR, Mod | 4 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, RIGIV, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urine Analysis Abnormal-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urticaria-non-SAE, NR, Mild | 5 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pruritus Generalized-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urticaria-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Urticaria-non-SAE, RIGIV, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vision Blurred-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Uterine Polyp-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, RIGIV, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vaginal Haemorrhage-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, Rboth, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vascular Access Complication-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pseudomonas Infection-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vertigo-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pain in Extremity-non-SAE, Rboth, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Diarrhoea-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Weight Decreased-non-SAE, RrHu, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Infection-non-SAE, NR, Mild | 7 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Palpitations-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Infection-non-SAE, NR, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Psoriasis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Infection-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Papule-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR Mild | 8 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Congestion-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Peptic Ulcer Haemorrhage-SAE, NR, Severe | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Congestion-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, NR, Mild | 11 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Congestion-non-SAE, RIGIV, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Periorbital Haematoma-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Discomfort-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vomiting-non-SAE, Rboth, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Mucosal Discolouration-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Peripheral Nerve Injury-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasal Turbinate Hypertrophy-non-SAE, NR, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nasopharyngitis-non-SAE, NR, Mild | 8 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pertussis-non-SAE, NR, Mod | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, NR, Mild | 17 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mod | 2 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, NR, Mod | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Petit Mal Epilepsy-SAE, NR, Severe | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, RIGIV, Mild | 1 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pyrexia-non-SAE, RIGIV, Mild | 6 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, RIGIV, Mod | 0 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Pharyngeal Erythema-non-SAE, NR, Mild | 3 Number of AEs |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z) | Nausea-non-SAE, Rboth, Mild | 4 Number of AEs |
Secondary
Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) | 0 Number of participants |
Secondary
Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis
Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis
Time frame: Throughout the study period (17 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis | 0 Number of participants |
Secondary
Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs
Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, \[administered via intravenous (IV) or subcutaneous (SC) route\], recombinant human hyaluronidase (rHuPH20) or both. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed.
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs | Including infections | 0.0 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs | Excluding infections | 0.0 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs | Including infections | 8.3 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs | Excluding infections | 8.3 Percentage of infusions |
Secondary
Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study
Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study
Time frame: At any time during the study
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study | Including infections | 0.0 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study | Excluding infections | 0.0 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study | Including infections | 5.9 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study | Excluding infections | 5.9 Percentage of infusions |
Secondary
Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion
Percentage of IV and SC (with recombinant human hyaluronidase \[rHuPH20\]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Including infections | 0.0 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Excluding infections | 0.0 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Including infections | 5.9 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Excluding infections | 5.9 Percentage of infusions |
Secondary
Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion
Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion | Including infections | 25.0 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion | Excluding infections | 25.0 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion | Including infections | 8.3 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion | Excluding infections | 8.3 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 Adverse Events (AEs)
Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % infusions with infusion stopped only | 0.0 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % infusions with infusion rate reduced only | 2.7 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % infusions with no changes to infusion rate | 95.9 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % infusions with interrupted infusion rate only | 1.4 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % infusions with no changes to infusion rate | 97.7 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % infusions with infusion rate reduced only | 1.7 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % infusions with infusion stopped only | 0.2 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % infusions with interrupted infusion rate only | 0.4 Percentage of infusions |
Secondary
Percentage of Infusions Resulting in ≥1 Temporally Associated AEs
Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Infusions Resulting in ≥1 Temporally Associated AEs | Including infections | 30.1 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions Resulting in ≥1 Temporally Associated AEs | Excluding infections | 28.8 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Resulting in ≥1 Temporally Associated AEs | Including infections | 24.5 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Resulting in ≥1 Temporally Associated AEs | Excluding infections | 22.8 Percentage of infusions |
Secondary
Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion
Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion | Including infections | 0.0 Percentage of infusions |
| Full Analysis Data Set (FADS) | Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion | Excluding infections | 0.0 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion | Including infections | 5.9 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion | Excluding infections | 0.0 Percentage of infusions |
Secondary
Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)
Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up. Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%. The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed.
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment) | 100.0 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment) | 100.0 Percentage of infusions |
Secondary
Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)
Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs). An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion.
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % participants with reduced infusion rate only | 6.9 Percentage of participants |
| Full Analysis Data Set (FADS) | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % participants with interrupted infusion rate only | 4.6 Percentage of participants |
| Full Analysis Data Set (FADS) | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % participants with infusion stopped only | 0.0 Percentage of participants |
| Full Analysis Data Set (FADS) | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % participants with no changes to infusion rate | 88.5 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % participants with no changes to infusion rate | 84.0 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % participants with reduced infusion rate only | 9.9 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % participants with infusion stopped only | 1.2 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs) | % participants with interrupted infusion rate only | 4.9 Percentage of participants |
Secondary
Percentage of Participants Reporting ≥1 Temporally Associated AEs
Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Participants Reporting ≥1 Temporally Associated AEs | Including infections | 66.7 Percentage of participants |
| Full Analysis Data Set (FADS) | Percentage of Participants Reporting ≥1 Temporally Associated AEs | Excluding infections | 63.2 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants Reporting ≥1 Temporally Associated AEs | Including infections | 86.4 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants Reporting ≥1 Temporally Associated AEs | Excluding infections | 82.7 Percentage of participants |
Secondary
Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs
Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Including infections | 36.8 Percentage of participants |
| Full Analysis Data Set (FADS) | Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Excluding infections | 34.5 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Including infections | 54.3 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs | Excluding infections | 46.9 Percentage of participants |
Secondary
Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) | 0.0 Percentage of participants |
Secondary
Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis
Further analysis for incidences of potential hemolysis included direct Coombs' test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis
Time frame: Throughout the study period (17 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis | 0 Percentage of participants |
Secondary
Percentage of Participants With ≥1 Local AE At Any Time During the Study
Percentage of participants With ≥1 local AE (including and excluding infections) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up at any time during the study
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Participants With ≥1 Local AE At Any Time During the Study | Including infections | 5.7 Percentage of participants |
| Full Analysis Data Set (FADS) | Percentage of Participants With ≥1 Local AE At Any Time During the Study | Excluding infections | 5.7 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants With ≥1 Local AE At Any Time During the Study | Including infections | 53.1 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants With ≥1 Local AE At Any Time During the Study | Excluding infections | 53.1 Percentage of participants |
Secondary
Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion
Percentage of participants With ≥1 local AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion | Including infections | 4.6 Percentage of participants |
| Full Analysis Data Set (FADS) | Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion | Excluding infections | 4.6 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion | Including infections | 51.9 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion | Excluding infections | 51.9 Percentage of participants |
Secondary
Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion
Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion
Time frame: During infusion or within 72 hours of completion of infusion
Population: Participants exposed to either or both study drugs
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Excluding infections | 60.9 Percentage of participants |
| Full Analysis Data Set (FADS) | Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Including infections | 64.4 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Including infections | 75.3 Percentage of participants |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion | Excluding infections | 67.9 Percentage of participants |
Secondary
Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site
Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site. An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion.
Time frame: During infusion or within 60 minutes of completion of the infusion
Population: Safety Analysis Data Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site | 100.0 Percentage of infusions |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site | 100.0 Percentage of infusions |
Secondary
Rate of Acute Physician Visits
Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365\*400+100-3)/(400\*12)= 30.436875 days.
Time frame: Monthly, for up to 17 months
Population: Full Analysis Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Rate of Acute Physician Visits | 0.33 Visits per month |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of Acute Physician Visits | 0.40 Visits per month |
Secondary
Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion
Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous \[IGIV\], 10% or recombinant human hyaluronidase \[rHuPH20\]), that occur at any time during the study divided by the total number of infusions
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion | Including infections | 0.25 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion | Excluding infections | 0.25 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion | Including infections | 0.22 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion | Excluding infections | 0.18 Number of AEs per infusion |
Secondary
Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant
Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous \[IGIV\], 10% or recombinant human hyaluronidase \[rHuPH20\]), that occur at any time during the study divided by the total number of participants
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant | Including infections | 0.00 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant | Excluding infections | 0.00 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant | Including infections | 0.09 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant | Excluding infections | 0.09 Number of AEs per participant |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthralgia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chronic Sinusitis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Discomfort-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Concussion-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthma-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Confusional State-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Distension-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Confusional State-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthma-non-SAE, NR, Mod | 0.022 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthropod Sting-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Aspiration-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | ADHD-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Acute Sinusitis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthenia-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthenia-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Constipation-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Contusion-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Contusion-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Acute Sinusitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Contusion-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthralgia-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Coombs Test Positive-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Costochondritis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthralgia-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cough-non-SAE, NR, Mild | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cough-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Increased-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cough-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthralgia-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cushingoid-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Adenoidal Hypertrophy-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cystitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Anxiety-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Deafness Neurosensory-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | BP Systolic Increased-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Decreased Appetite-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fall-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Decreased Appetite-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Body Fat Disorder-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dehydration-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dysmenorrhoea-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Device Failure-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Back Injury-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Device Failure-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Body Tinea-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea-non-SAE, NR, Mild | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Adrenocortical Insufficiency Acute-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Back Injury-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Body Tinea-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Back Pain-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea Infectious-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Back Pain-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diastolic Dysfunction-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Disaccharide Metabolism Disorder-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bacterial Prostatitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Disturbance in Attention-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bone Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diverticulitis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthma-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dizziness-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Allergic Respiratory Symptom-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dizziness-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthritis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dizziness-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Breast Pain-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dizziness-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthropod Bite-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Drug Eruption-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blepharitis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dry Eye-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dry Mouth-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blister-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dry Skin-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Allergic Sinusitis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspepsia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Decreased-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspepsia-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Decreased-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspepsia-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Burning Sensation-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dysphagia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Increased-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dysphagia-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cardiac Murmur-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspnoea-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Alopecia-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspnoea-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspnoea-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Urea Increased-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ear Infection-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchal Hyperreactivity-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ear Infection-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Tenderness-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ear Pain-non-SAE, NR, Mild | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchitis-non-SAE, NR, Mild | 0.011 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ear Pain-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Decreased Appetite-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ecchymosis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchitis-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eczema-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Lower-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eczema-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchitis-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eczema-non-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Hernia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eosinophil Count-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchospasm-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Epitaxis-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dysuria-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Epitaxis-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Burn Infection-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Burning Sensation-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Burning Sensation-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthropathy-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eustachian Tube Dysfunction-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bursitis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Excoriation-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Extravasation Blood-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bursitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eye Irritation-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eye Pruritus-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Candidiasis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eye Swelling-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Candidiasis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fall-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cellulitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, RIGIV, Mild | 0.022 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthropod Sting-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cellulitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Acne-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Feeling Abnormal-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cellulitis-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Feeling Cold-non-SAE, RIGIV, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cerumen Impaction-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Flatulence-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Flatulence-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cervical Dysplasia-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Food Poisoning-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Adnexa Uteri Cyst-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Free Haemoglobin Present-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cheilitis-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Free Haemoglobin Present-non-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthenia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chest Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dental Caries-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Animal Bite-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dental Caries-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chills-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Depressed Mood-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Antibody Test Positive-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Depression-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chills-non-SAE, RIGIV, Mild | 0.016 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermal Cyst-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Anxiety-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chills-non-SAE, RIGIV, Mod | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Aphthous Stomatitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Acneiform-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chills-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Contact-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Acarodermatitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Contact-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | COPD-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Infected-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arteriosclerosis Coronary Artery-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Infected-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | COPD-non-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Infected-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fall-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dysmenorrhoea-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain-non-SAE, Rboth, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Lower-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain Upper-non-SAE, Rboth, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Tenderness-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Acne-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Acute Sinusitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Adenoidal Hypertrophy-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Adnexa Uteri Cyst-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Adrenocortical Insufficiency Acute-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Allergic Respiratory Symptom-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Alopecia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Animal Bite-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Antibody Test Positive-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthritis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthropod Sting-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthropod Sting-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthenia-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthenia-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Back Pain-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Decreased-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Increased-non-SAE, RrHu, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Urea Increased-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Body Fat Disorder-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Body Tinea-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Body Tinea-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bone Pain-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Breast Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Burning Sensation-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cellulitis-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Constipation-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cough-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Distension-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Hernia-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Pain-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Acarodermatitis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Acute Sinusitis-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Allergic Sinusitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Aphthous Stomatitis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arteriosclerosis Coronary Artery-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Abdominal Discomfort-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthropod Bite-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Aspiration-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthenia-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthma-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthralgia-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthralgia-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthralgia-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Anxiety-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Anxiety-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | ADHD-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthma-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Back Injury-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Asthma-non-SAE, NR, Mod | 0.019 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Back Injury-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Back Pain-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bacterial Prostatitis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthralgia-non-SAE, RIGIV, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Arthropathy-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blepharitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blister-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Decreased-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Increased-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | BP Systolic Increased-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchal Hyperreactivity-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchitis-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchitis-non-SAE, NR, Mod | 0.007 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchitis-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bronchospasm-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Burn Infection-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Burning Sensation-non-SAE, RIGIV, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Burning Sensation-non-SAE, RrHu, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bursitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Bursitis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Candidiasis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Candidiasis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cardiac Murmur-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cellulitis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cellulitis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cerumen Impaction-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cervical Dysplasia-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cheilitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chest Pain-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chills-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chills-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chills-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chills-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | COPD-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | COPD-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chronic Sinusitis-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Chronic Sinusitis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Concussion-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Confusional State-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Confusional State-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Contusion-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Contusion-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Contusion-non-SAE, RIGIV, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Coombs Test Positive-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Costochondritis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cough-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cough-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cushingoid-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Cystitis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Deafness Neurosensory-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Decreased Appetite-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Decreased Appetite-non-SAE, RrHu, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Decreased Appetite-non-SAE, Rboth, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Infected-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Device Failure-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Device Failure-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea Infectious-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diastolic Dysfunction-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Disaccharide Metabolism Disorder-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Disturbance in Attention-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diverticulitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dizziness-non-SAE, NR, Mild | 0.006 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dizziness-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dizziness-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dizziness-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Drug Eruption-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dry Eye-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dry Mouth-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dry Skin-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspepsia-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspepsia-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspepsia-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dysphagia-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dysphagia-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspnoea-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspnoea-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dyspnoea-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dysuria-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ear Infection-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ear Infection-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ear Pain-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ear Pain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Ecchymosis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eczema-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eczema-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eczema-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eosinophil Count-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Epitaxis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Epitaxis-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, RIGIV, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, RrHu, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Erythema-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eustachian Tube Dysfunction-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Excoriation-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Extravasation Blood-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eye Irritation-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eye Pruritus-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Eye Swelling-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fall-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Diarrhoea-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, RIGIV, Mild | 0.007 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Fatigue-non-SAE, Rboth, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Feeling Abnormal-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Feeling Cold-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Flatulence-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Flatulence-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Food Poisoning-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Free Haemoglobin Present-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Free Haemoglobin Present-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dehydration-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dental Caries-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dental Caries-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Depressed Mood-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Depression-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermal Cyst-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Acneiform-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Contact-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Contact-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Infected-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F) | Dermatitis Infected-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphadenitis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Heart Rate Increased-non-SAE, RIGIV, Mild | 0.011 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Grand Mal Convulsion-non-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Heat Rash-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis Bacterial-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, RrHu, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Heat Stroke-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Grand Mal Convulsion-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Herpes Simplex Ophthalmic-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, Rboth, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Herpes Zoster-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pruritus-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gravitational Oedema-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hiatus Hernia-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hot Flush-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hyperaesthesia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Swelling-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Groin Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypercholesterolaemia-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Warmth-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Swelling-non-SAE, Rboth, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hyperkeratosis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Groin Pain-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Ingrowing Nail-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypertension-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Injection Site Erythema-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis Viral-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Injury-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypertension-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Insomnia-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Groin Pain-non-SAE, RrHu, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Intervertebral Disc Protrusion-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypertension-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haematoma-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypertonia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Effusion-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haematoma-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Effusion-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypothyroidism-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Injury-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis Viral-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Range of Motion Decreased-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Idiopathic Urticaria-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Sprain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haematuria-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Sprain-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Increased Upper Airway Secretion-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Swelling-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gait Disturbance-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Jugular Vein Distension-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infected Bites-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lethargy-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haemoglobin Abnormal-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lethargy-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infected Bites-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Ligament Injury-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastrointestinal Haemorrhage-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Ligament Sprain-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infection-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Limb Injury-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lip Injury-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haemorrhoids-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lip Ulceration-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Influenza-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Local Swelling-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lung Infection-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Local Swelling-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Influenza-non-SAE, NR, Mod | 0.011 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Localised Infection-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hand Fracture-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Localised Oedema-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Influenza Like Illness-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Localised Oedema-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lung Infection-non-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymph Gland Infection-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, NR, Mild | 0.036 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymph Node Pain-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Genital Herpes-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymph Node Palpable-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphadenopathy-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphangitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphocyte Count Decreased-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphoedema-non-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Discomfort-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Discomfort-non-SAE, RrHu, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, RrHu, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, RIGIV, Mild | 0.068 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Memory Impairment-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymph Node Pain-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Erythema-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, RIGIV, Mod | 0.033 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Erythema-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, RIGIV, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Genital Swelling-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Molluscum Contagiosum-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, RIGIV, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Mouth Ulceration-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Multiple Sclerosis Relapse-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Fatigue-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Extravasation-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Injury-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Haematoma-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Spasms-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Spasms-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Haemorrhage-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Strain-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Goitre-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Strain-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Hypersensitivity-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscular Weakness-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Hypersensitivity-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Mass-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Pain-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Stiffness-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, NR, Mild | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Mass-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gout-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hearing Impaired-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, Rboth, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Groin Pain-non-SAE, RrHu, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hot Flush-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Extravasation-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Limb Injury-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lung Infection-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymph Node Palpable-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphadenitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Pain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gait Disturbance-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis Bacterial-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis Viral-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastroenteritis Viral-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastrointestinal Haemorrhage-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Genital Herpes-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Genital Swelling-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Goitre-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gout-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Grand Mal Convulsion-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Grand Mal Convulsion-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Gravitational Oedema-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Groin Pain-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Groin Pain-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haematoma-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haematoma-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haematuria-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haemoglobin Abnormal-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Haemorrhoids-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hand Fracture-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, NR, Mild | 0.014 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, RIGIV, Mild | 0.012 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, RIGIV, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, RIGIV, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, Rboth, Mild | 0.008 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-non-SAE, Rboth, Mod | 0.007 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Headache-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hearing Impaired-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Heart Rate Increased-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Heat Rash-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Heat Stroke-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Herpes Simplex Ophthalmic-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Herpes Zoster-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hiatus Hernia-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hyperaesthesia-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypercholesterolaemia-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hyperkeratosis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypertension-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypertension-non-SAE, RIGIV, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypertension-non-SAE, RIGIV, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypertonia-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Hypothyroidism-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Idiopathic Urticaria-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Increased Upper Airway Secretion-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infected Bites-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infected Bites-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infection-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Influenza-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Influenza-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Influenza Like Illness-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Discomfort-non-SAE, RIGIV, Mild | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Discomfort-non-SAE, RrHu, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mild | 0.013 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mod | 0.007 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Erythema-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Erythema-non-SAE, RrHu, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mild | 0.018 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Haematoma-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Haemorrhage-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Hypersensitivity-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Hypersensitivity-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Mass-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Mass-non-SAE, Rboth, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mild | 0.011 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mod | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, RrHu, Mild | 0.031 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, RrHu, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, Rboth, Mild | 0.017 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, Rboth, Mod | 0.014 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pain-non-SAE, Rboth, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pruritus-non-SAE, RIGIV, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pruritus-non-SAE, RrHu, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mild | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Swelling-non-SAE, RIGIV, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Swelling-non-SAE, Rboth, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Infusion Site Warmth-non-SAE, Rboth, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Ingrowing Nail-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Injection Site Erythema-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Injury-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Insomnia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Intervertebral Disc Protrusion-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Effusion-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Effusion-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Injury-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Range of Motion Decreased-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Sprain-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Sprain-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Joint Swelling-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Jugular Vein Distension-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lethargy-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lethargy-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Ligament Injury-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Ligament Sprain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lip Injury-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lip Ulceration-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Local Swelling-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Local Swelling-non-SAE, Rboth, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Localised Infection-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Localised Oedema-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Localised Oedema-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lung Infection-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymph Gland Infection-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymph Node Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymph Node Pain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphadenopathy-non-SAE, NR, Mild | 0.007 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphangitis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphocyte Count Decreased-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Lymphoedema-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, RrHu, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Malaise-non-SAE, RrHu, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Memory Impairment-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, RIGIV, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, RIGIV, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Migraine-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Molluscum Contagiosum-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Mouth Ulceration-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Multiple Sclerosis Relapse-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Fatigue-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Injury-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Spasms-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Spasms-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Strain-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscle Strain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Muscular Weakness-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Musculoskeletal Stiffness-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, RIGIV, Mild | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M) | Myalgia-non-SAE, RIGIV, Mod | 0.001 Number of AEs per infusion |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Night Sweats-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Papular-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Failure-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | White Blood Cells Urine Positive-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Rate Increased-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Tract Congestion-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Night Sweats-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, RIGIV, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Congestion-non-SAE, NR, Mild | 0.011 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Tract Infection Viral-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rhinitis Allergic-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nodule-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rhinitis Allergic-non-SAE, NR, Mod | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rhinitis Allergic-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Peptic Ulcer Haemorrhage-SAE, NR, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rhinorrhoea-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Road Traffic Accident-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Scleritis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Scleritis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Congestion-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Scratch-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, RIGIV, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Seborrhoeic Dermatitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema Genital-non-SAE, Rboth, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sicca Syndrome-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, RIGIV, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinus Congestion-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Pain-non-SAE, RrHu, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinus Headache-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinusitis-non-SAE, NR, Mild | 0.016 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema Peripheral-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinusitis-non-SAE, NR, Mod | 0.036 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinusitis-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Congestion-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinusitis-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Palpitations-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skeletal Injury-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema Peripheral-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skeletal Injury-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Papule-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pharyngeal Erythema-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Laceration-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Periorbital Haematoma-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Laceration-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Lesion-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema Peripheral-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Lesion-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Peripheral Nerve Injury-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Lesion-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Discomfort-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Papilloma-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pertussis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Spinal Osteoarthritis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oesophagitis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Squamous Cell Carcinoma-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Petit Mal Epilepsy-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Status Epilepticus-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pneumonia-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Suicidal Ideation-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pharyngitis-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sunburn-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Onychomycosis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Swelling-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pharyngitis-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Swelling-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Mucosal Discolouration-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Syncope-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pharyngitis Streptococcal-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tachycardia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Candidiasis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tachycardia-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pneumonia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Therapy Cessation-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Post Procedural Infection-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Thrombosis-non-SAE, NR, Severe | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Fungal Infection-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Thrombosis-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pneumonia Bacterial-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tinea Infection-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Turbinate Hypertrophy-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tongue Coated-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Post Procedural Infection-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tonsillar Hypertrophy-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Herpes-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tonsillar Hypertrophy-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Osteopenia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tooth Abscess-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Postictal Paralysis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tooth Abscess-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Herpes-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tooth Impacted-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Postoperative Wound Infection-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tooth Infection-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, NR, Mild | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Toothache-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Procedural Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tongue Injury-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Pain-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tremor-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Procedural Pain-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tricuspid Valve Incompetence-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Maculo-Papular-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tympanic Membrane Disorder-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Productive Cough-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tympanic Membrane Hyperaemia-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Upper Airway Cough Syndrome-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mild | 0.019 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urinary Tract Infection-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urinary Tract Infection-non-SAE, NR, Mod | 0.014 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Osteopenia-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urine Analysis Abnormal-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urticaria-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urticaria-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus Generalized-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urticaria-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, RIGIV, Mild | 0.019 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Uterine Polyp-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pseudomonas Infection-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Osteoarthritis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vascular Access Complication-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Psoriasis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vertigo-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Pustular-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Diarrhoea-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, NR, Mild | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Infection-non-SAE, NR, Mild | 0008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Infection-non-SAE, NR, Mod | 0.008 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, NR, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Infection-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Hyperpigmentation-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, RIGIV, Mild | 0.011 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Osteoporosis-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vision Blurred-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, RIGIV, Mod | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, Rboth, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, NR, Mild | 0.014 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Otitis Externa-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rales-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, RIGIV, Mild | 0.011 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasopharyngitis-non-SAE, NR, Mild | 0.011 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, RIGIV, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rales-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, RIGIV, Severe | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Otitis Externa-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, Rboth, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash-non-SAE, NR, Mild | 0.005 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vulvovaginal Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Neck Pain-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Weight Decreased-non-SAE, RrHu, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Weight Decreased-non-SAE, RrHu, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Otitis Media-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Wheezing-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Erythematous-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | WBC Count Decreased-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vaginal Haemorrhage-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Pustular-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | WBC Urine Positive-non-SAE, RIGIV Mild | 0.003 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | WBC Urine Positive-non-SAE, RIGIV Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Papule-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Petit Mal Epilepsy-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Productive Cough-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Maculo-Papular-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Laceration-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Congestion-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Congestion-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Congestion-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Discomfort-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Mucosal Discolouration-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasopharyngitis-non-SAE, NR, Mild | 0.007 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, NR, Mild | 0.015 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nausea-non-SAE, Rboth, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Neck Pain-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Night Sweats-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Night Sweats-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nodule-non-SAE, Rboth, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema Genital-non-SAE, Rboth, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema Peripheral-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema Peripheral-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oedema Peripheral-non-SAE, Rboth, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oesophagitis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Onychomycosis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Candidiasis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Fungal Infection-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Herpes-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Herpes-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Pain-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oral Pain-non-SAE, RrHu, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Osteoarthritis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Osteopenia-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Osteopenia-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Osteoporosis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Otitis Externa-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Otitis Externa-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Otitis Media-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, RIGIV, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, RIGIV, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, Rboth, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pain in Extremity-non-SAE, Rboth, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Palpitations-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Peptic Ulcer Haemorrhage-SAE, NR, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Periorbital Haematoma-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Peripheral Nerve Injury-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pertussis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pharyngeal Erythema-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pharyngitis-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pharyngitis-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pharyngitis Streptococcal-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pneumonia-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pneumonia-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pneumonia Bacterial-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Post Procedural Infection-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Post Procedural Infection-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Postictal Paralysis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Postoperative Wound Infection-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Procedural Pain-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Procedural Pain-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pruritus Generalized-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pseudomonas Infection-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Psoriasis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, NR, Mild | 0.010 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, RIGIV, Mild | 0.005 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, RIGIV, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Pyrexia-non-SAE, Rboth, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rales-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rales-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Erythematous-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Pustular-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Pustular-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rash Papular-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Failure-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Rate Increased-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Tract Congestion-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Respiratory Tract Infection Viral-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rhinitis Allergic-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rhinitis Allergic-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rhinitis Allergic-non-SAE, RIGIV, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Rhinorrhoea-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Road Traffic Accident-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Scleritis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Scleritis-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Scratch-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Seborrhoeic Dermatitis-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sicca Syndrome-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinus Congestion-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinus Headache-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinusitis-non-SAE, NR, Mild | 0.022 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinusitis-non-SAE, NR, Mod | 0.023 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinusitis-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sinusitis-non-SAE, RIGIV, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skeletal Injury-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skeletal Injury-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Hyperpigmentation-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Laceration-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Lesion-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Lesion-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Lesion-non-SAE, RIGIV, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Skin Papilloma-non-SAE, NR, Mod | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Spinal Osteoarthritis-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Squamous Cell Carcinoma-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Status Epilepticus-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Suicidal Ideation-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Sunburn-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Swelling-non-SAE, Rboth, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Swelling-non-SAE, Rboth, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Syncope-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tachycardia-non-SAE, NR, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tachycardia-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Therapy Cessation-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Thrombosis-non-SAE, NR, Severe | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Thrombosis-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tinea Infection-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tongue Coated-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tonsillar Hypertrophy-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tonsillar Hypertrophy-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tooth Abscess-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tooth Abscess-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tooth Impacted-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tooth Infection-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Toothache-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tongue Injury-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tremor-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tricuspid Valve Incompetence-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tympanic Membrane Disorder-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Tympanic Membrane Hyperaemia-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Upper Airway Cough Syndrome-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mild | 0.030 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mod | 0.009 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urinary Tract Infection-non-SAE, NR, Mild | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urinary Tract Infection-non-SAE, NR, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urine Analysis Abnormal-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urticaria-non-SAE, NR, Mild | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urticaria-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Urticaria-non-SAE, RIGIV, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Uterine Polyp-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vaginal Haemorrhage-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vascular Access Complication-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vertigo-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Diarrhoea-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Infection-non-SAE, NR, Mild | 0.006 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Infection-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Infection-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR Mild | 0.007 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vision Blurred-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mod | 0.002 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, NR, Mild | 0.006 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, NR, Mod | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, RIGIV, Mild | 0.003 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, RIGIV, Mod | 0.004 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, RIGIV, Severe | 0 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vomiting-non-SAE, Rboth, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Vulvovaginal Pruritus-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Weight Decreased-non-SAE, RrHu, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Weight Decreased-non-SAE, RrHu, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Wheezing-non-SAE, NR, Mod | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | WBC Count Decreased-non-SAE, RIGIV, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | White Blood Cells Urine Positive-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z) | Nasal Turbinate Hypertrophy-non-SAE, NR, Mild | 0.001 Number of AEs per infusion |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Body Tinea-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | COPD-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | COPD-non-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cardiac Murmur-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chronic Sinusitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chronic Sinusitis-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthralgia-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Concussion-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Acarodermatitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Confusional State-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Confusional State-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cellulitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Acne-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Acute Sinusitis-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Body Tinea-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Acute Sinusitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Constipation-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cellulitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Contusion-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Adenoidal Hypertrophy-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Contusion-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Adnexa Uteri Cyst-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Contusion-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Coombs Test Positive-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bacterial Prostatitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Costochondritis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Adrenocortical Insufficiency Acute-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cough-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cervical Dysplasia-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cough-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Allergic Respiratory Symptom-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cushingoid-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Allergic Sinusitis-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cystitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bone Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Deafness Neurosensory-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Alopecia-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Decreased Appetite-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Aphthous Stomatitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Decreased Appetite-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Animal Bite-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Decreased Appetite-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dehydration-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Breast Pain-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dental Caries-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Depressed Mood-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Depression-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Anxiety-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermal Cyst-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthropod Sting-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Anxiety-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Acneiform-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchal Hyperreactivity-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Contact-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cough-non-SAE, NR, Mild | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Infected-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arteriosclerosis Coronary Artery-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Infected-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthenia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Infected-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthralgia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Device Failure-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthralgia-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Device Failure-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchitis-non-SAE, NR, Mild | 0.046 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea-non-SAE, NR, Mild | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthralgia-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dental Caries-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthritis-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthropathy-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea Infectious-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchitis-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diastolic Dysfunction-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthropod Bite-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Disaccharide Metabolism Disorder-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Burn Infection-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Disturbance in Attention-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthropod Sting-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diverticulitis-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Contact-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dizziness-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dizziness-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Aspiration-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dizziness-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Discomfort-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dizziness-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Back Injury-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Drug Eruption-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthenia-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dry Eye-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Distension-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dry Mouth-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthenia-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dry Skin-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Burning Sensation-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dysmenorrhoea-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthma-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspepsia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Hernia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspepsia-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthma-non-SAE, NR, Mod | 0.092 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspepsia-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Antibody Test Positive-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dysphagia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthma-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dysphagia-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspnoea-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | ADHD-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspnoea-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Burning Sensation-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspnoea-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dysuria-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Back Pain-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ear Infection-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Urea Increased-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ear Infection-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blepharitis-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ear Pain-non-SAE, NR, Mild | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ear Pain-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blister-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ecchymosis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Decreased-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eczema-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bursitis-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eczema-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Decreased-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eczema-non-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eosinophil Count-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Increased-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Epitaxis-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Epitaxis-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Back Injury-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Increased-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Lower-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | BP Systolic Increased-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bursitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchitis-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eustachian Tube Dysfunction-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Excoriation-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchospasm-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Extravasation Blood-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eye Irritation-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Body Fat Disorder-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eye Pruritus-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Burning Sensation-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eye Swelling-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cellulitis-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fall-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fall-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cerumen Impaction-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Candidiasis-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cheilitis-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, RIGIV, Mild | 0.092 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chest Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Back Pain-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Feeling Abnormal-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chills-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Feeling Cold-non-SAE, RIGIV, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Flatulence-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chills-non-SAE, RIGIV, Mild | 0.069 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Flatulence-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Candidiasis-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Food Poisoning-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chills-non-SAE, RIGIV, Mod | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Free Haemoglobin Present-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Tenderness-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Free Haemoglobin Present-non-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chills-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dehydration-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Acne-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Adenoidal Hypertrophy-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Allergic Respiratory Symptom-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Aphthous Stomatitis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthralgia-non-SAE, NR, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthralgia-non-SAE, NR, Mod | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Back Injury-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Back Pain-non-SAE, NR, Mod | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bacterial Prostatitis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blister-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Increased-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | BP Systolic Increased-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Urea Increased-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Body Fat Disorder-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Body Tinea-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Body Tinea-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bone Pain-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Breast Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchal Hyperreactivity-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchitis-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Burning Sensation-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Burning Sensation-non-SAE, RIGIV, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Burning Sensation-non-SAE, RrHu, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bursitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bursitis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Candidiasis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Candidiasis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cardiac Murmur-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cellulitis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cellulitis-non-SAE, NR, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cervical Dysplasia-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Confusional State-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Confusional State-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Contusion-non-SAE, RIGIV, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cough-non-SAE, NR, Mild | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Decreased Appetite-non-SAE, Rboth, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dental Caries-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dental Caries-non-SAE, NR, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermal Cyst-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Discomfort-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Distension-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Hernia-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain-non-SAE, Rboth, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Lower-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, Rboth, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Tenderness-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Tenderness-non-SAE, RIGIV, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Acarodermatitis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Acute Sinusitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Acute Sinusitis-non-SAE, NR, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Adnexa Uteri Cyst-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Adrenocortical Insufficiency Acute-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Allergic Sinusitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Alopecia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Animal Bite-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Antibody Test Positive-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Anxiety-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Anxiety-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Aphthous Stomatitis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arteriosclerosis Coronary Artery-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthralgia-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthralgia-non-SAE, RIGIV, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthritis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthropathy-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthropod Bite-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthropod Sting-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Arthropod Sting-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Aspiration-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthenia-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthenia-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthenia-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthma-non-SAE, NR, Mild | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthma-non-SAE, NR, Mod | 0.259 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Asthma-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | ADHD-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Back Injury-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Back Pain-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blepharitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Decreased-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Decreased-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Increased-non-SAE, RIGIV, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Blood Pressure Increased-non-SAE, RrHu, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchitis-non-SAE, NR, Mod | 0.099 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchitis-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Bronchospasm-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Burn Infection-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cellulitis-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cerumen Impaction-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cheilitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chest Pain-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chills-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chills-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chills-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chills-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | COPD-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | COPD-non-SAE, NR, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chronic Sinusitis-non-SAE, NR, Mild | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Chronic Sinusitis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Concussion-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Allergic-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Conjunctivitis Bacterial-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Constipation-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Contusion-non-SAE, NR, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Contusion-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Coombs Test Positive-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Costochondritis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cough-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cough-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cushingoid-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Cystitis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Deafness Neurosensory-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Decreased Appetite-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Decreased Appetite-non-SAE, RrHu, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Abdominal Pain Upper-non-SAE, NR, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Depressed Mood-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Depression-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Acneiform-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Contact-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Contact-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Infected-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Infected-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dermatitis Infected-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Device Failure-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Device Failure-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea-non-SAE, NR, Mild | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea-non-SAE, NR, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea Haemorrhagic-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diarrhoea Infectious-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diastolic Dysfunction-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Disaccharide Metabolism Disorder-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Disturbance in Attention-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Diverticulitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dizziness-non-SAE, NR, Mild | 0.086 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dizziness-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dizziness-non-SAE, RIGIV, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dizziness-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Drug Eruption-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dry Eye-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dry Mouth-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dry Skin-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dysmenorrhoea-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspepsia-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspepsia-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspepsia-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dysphagia-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dysphagia-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspnoea-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspnoea-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dyspnoea-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Dysuria-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ear Infection-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ear Infection-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ear Pain-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ear Pain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Ecchymosis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eczema-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eczema-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eczema-non-SAE, NR, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eosinophil Count-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Epitaxis-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Epitaxis-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, RIGIV, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, RrHu, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Erythema-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eustachian Tube Dysfunction-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Excoriation-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Extravasation Blood-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eye Irritation-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eye Pruritus-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Eye Swelling-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fall-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fall-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, NR, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, RIGIV, Mild | 0.099 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, RIGIV, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Fatigue-non-SAE, Rboth, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Feeling Abnormal-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Feeling Cold-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Flatulence-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Flatulence-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Food Poisoning-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Free Haemoglobin Present-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F) | Free Haemoglobin Present-non-SAE, NR, Severe | 0 Number of AEs per participant |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, RIGIV, Mod | 0.138 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infected Bites-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Influenza-non-SAE, NR, Mod | 0.046 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Swelling-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Sprain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lip Ulceration-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymph Gland Infection-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymph Node Palpable-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphoedema-non-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Mouth Ulceration-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Multiple Sclerosis Relapse-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Spasms-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Spasms-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Stiffness-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, RIGIV, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hearing Impaired-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Heart Rate Increased-non-SAE, RIGIV, Mild | 0.046 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Heat Rash-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Heat Stroke-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Herpes Simplex Ophthalmic-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Herpes Zoster-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hiatus Hernia-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hot Flush-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hyperaesthesia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypercholesterolaemia-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hyperkeratosis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypertension-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypertension-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypertension-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypertonia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypothyroidism-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Idiopathic Urticaria-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Increased Upper Airway Secretion-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infected Bites-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infection-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Influenza-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Influenza Like Illness-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Discomfort-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Discomfort-non-SAE, RrHu, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Erythema-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Erythema-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Extravasation-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Haematoma-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Haemorrhage-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Hypersensitivity-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Hypersensitivity-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Mass-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Mass-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, RrHu, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, Rboth, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pruritus-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Swelling-non-SAE, Rboth, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Warmth-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Ingrowing Nail-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Injection Site Erythema-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Injury-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Insomnia-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Intervertebral Disc Protrusion-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Effusion-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Effusion-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Injury-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Range of Motion Decreased-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Sprain-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Swelling-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Jugular Vein Distension-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lethargy-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lethargy-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Ligament Injury-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Ligament Sprain-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Limb Injury-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lip Injury-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Local Swelling-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Local Swelling-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Localised Infection-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Localised Oedema-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Localised Oedema-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lung Infection-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lung Infection-non-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymph Node Pain-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymph Node Pain-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphadenitis-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphadenopathy-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphangitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphocyte Count Decreased-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, RrHu, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Memory Impairment-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, RIGIV, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Molluscum Contagiosum-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Fatigue-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Injury-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Strain-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Strain-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscular Weakness-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Pain-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Pain-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, NR, Mild | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gait Disturbance-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis Bacterial-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis Viral-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis Viral-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastrointestinal Haemorrhage-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Genital Herpes-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Genital Swelling-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Goitre-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gout-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Grand Mal Convulsion-non-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Grand Mal Convulsion-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gravitational Oedema-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Groin Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Groin Pain-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haematoma-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haematoma-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haematuria-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haemoglobin Abnormal-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haemorrhoids-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hand Fracture-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, NR, Mild | 0.149 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, RIGIV, Mild | 0.287 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Groin Pain-non-SAE, RrHu, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Multiple Sclerosis Relapse-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Herpes Simplex Ophthalmic-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastrointestinal Haemorrhage-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Insomnia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mild | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mod | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, Rboth, Mod | 0.198 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mild | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Groin Pain-non-SAE, RrHu, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Intervertebral Disc Protrusion-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Spasms-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymph Node Pain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Spasms-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphadenitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphangitis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphocyte Count Decreased-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Irritable Bowel Syndrome-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Memory Impairment-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Effusion-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, RIGIV, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Strain-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Effusion-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Fatigue-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Injury-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, NR, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Injury-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscular Weakness-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Muscle Strain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Pain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Range of Motion Decreased-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Stiffness-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, NR, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Sprain-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, RIGIV, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, RIGIV, Mod | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastrooesophageal Reflux Disease-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, RIGIV, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Sprain-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, Rboth, Mild | 0.011 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Chest Pain-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, Rboth, Mod | 0.099 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Joint Swelling-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haematoma-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hearing Impaired-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Jugular Vein Distension-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Heart Rate Increased-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Musculoskeletal Chest Pain-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Heat Rash-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lethargy-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Heat Stroke-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Genital Herpes-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lethargy-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Herpes Zoster-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hand Fracture-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hiatus Hernia-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Ligament Injury-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hot Flush-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Genital Swelling-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hyperaesthesia-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Ligament Sprain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypercholesterolaemia-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, NR, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hyperkeratosis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Limb Injury-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypertension-non-SAE, NR, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haematoma-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypertension-non-SAE, RIGIV, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lip Injury-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypertension-non-SAE, RIGIV, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lip Ulceration-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypertonia-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Goitre-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Hypothyroidism-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Local Swelling-non-SAE, RIGIV, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Idiopathic Urticaria-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Increased Upper Airway Secretion-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Local Swelling-non-SAE, Rboth, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infected Bites-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infected Bites-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, RIGIV, Mild | 0.173 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infection-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Localised Infection-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Influenza-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Influenza-non-SAE, NR, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, RIGIV, Mild | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Influenza Like Illness-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Localised Oedema-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gout-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Related Reaction-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Localised Oedema-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Myalgia-non-SAE, Rboth, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Related Reaction-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lung Infection-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Discomfort-non-SAE, RIGIV, Mild | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haematuria-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Discomfort-non-SAE, RrHu, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lung Infection-non-SAE, NR, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mild | 0.185 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymph Gland Infection-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Discomfort-non-SAE, Rboth, Mod | 0.099 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gait Disturbance-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Erythema-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymph Node Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Erythema-non-SAE, RrHu, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Grand Mal Convulsion-non-SAE, NR, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mild | 0.247 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymph Node Palpable-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Erythema-non-SAE, Rboth, Mod | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Extravasation-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, NR, Mild | 0.198 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Haematoma-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphadenopathy-non-SAE, NR, Mild | 0.099 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Haemorrhage-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Hypersensitivity-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Grand Mal Convulsion-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Hypersensitivity-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Lymphoedema-non-SAE, NR, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Mass-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Mass-non-SAE, Rboth, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haemoglobin Abnormal-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Oedema-non-SAE, Rboth, Mod | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Injury-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, RIGIV, Mild | 0.148 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, RrHu, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, RrHu, Mild | 0.432 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gravitational Oedema-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, RrHu, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Malaise-non-SAE, RrHu, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, Rboth, Mild | 0.235 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis Bacterial-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Headache-non-SAE, NR, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pain-non-SAE, Rboth, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis Viral-non-SAE, NR, Mild | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pruritus-non-SAE, RIGIV, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pruritus-non-SAE, RrHu, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Groin Pain-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, NR, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Pruritus-non-SAE, Rboth, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis Viral-non-SAE, NR, Mod | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Reaction-non-SAE, Rboth, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Swelling-non-SAE, RIGIV, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Haemorrhoids-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Migraine-non-SAE, RIGIV, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Swelling-non-SAE, Rboth, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Gastroenteritis Viral-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Swelling-non-SAE, Rboth, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Groin Pain-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Infusion Site Warmth-non-SAE, Rboth, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Molluscum Contagiosum-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Ingrowing Nail-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Mouth Ulceration-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M) | Injection Site Erythema-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
Secondary
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (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 Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe Preferred terms abbreviated: Resp.-Respiratory WBC - White blood cells
Time frame: Throughout the study period (17 months)
Population: Safety Analysis Data Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Weight Decreased-non-SAE, RrHu, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Osteopenia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Otitis Externa-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, RIGIV, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rhinitis Allergic-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rhinitis Allergic-non-SAE, NR, Mod | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Scleritis-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skeletal Injury-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Weight Decreased-non-SAE, RrHu, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Wheezing-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | WBC Count Decreased-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | White Blood Cells Urine Positive-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | WBC Urine Positive-non-SAE, RIGIV Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Congestion-non-SAE, NR, Mild | 0.046 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Congestion-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Congestion-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Discomfort-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Mucosal Discolouration-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Turbinate Hypertrophy-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasopharyngitis-non-SAE, NR, Mild | 0.046 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, RIGIV, Mild | 0.080 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Neck Pain-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Night Sweats-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Night Sweats-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nodule-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema Genital-non-SAE, Rboth, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema Peripheral-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema Peripheral-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema Peripheral-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oesophagitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Onychomycosis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Candidiasis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Fungal Infection-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Herpes-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Herpes-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Pain-non-SAE, RrHu, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Osteoarthritis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Osteopenia-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Osteoporosis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Otitis Externa-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Otitis Media-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, RIGIV, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, RIGIV, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Palpitations-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Papule-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Peptic Ulcer Haemorrhage-SAE, NR, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Periorbital Haematoma-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Peripheral Nerve Injury-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pertussis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Petit Mal Epilepsy-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pharyngeal Erythema-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pharyngitis-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pharyngitis-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pharyngitis Streptococcal-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pneumonia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pneumonia-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pneumonia Bacterial-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Post Procedural Infection-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Post Procedural Infection-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Postictal Paralysis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Postoperative Wound Infection-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Procedural Pain-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Procedural Pain-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Productive Cough-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus Generalized-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pseudomonas Infection-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Psoriasis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, NR, Mild | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, RIGIV, Mild | 0.046 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, RIGIV, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rales-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rales-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Erythematous-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Maculo-Papular-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Pustular-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Pustular-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Papular-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Failure-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Rate Increased-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Tract Congestion-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Tract Infection Viral-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rhinitis Allergic-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rhinorrhoea-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Road Traffic Accident-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Scleritis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Scratch-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Seborrhoeic Dermatitis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sicca Syndrome-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinus Congestion-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinus Headache-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinusitis-non-SAE, NR, Mild | 0.069 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinusitis-non-SAE, NR, Mod | 0.149 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinusitis-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinusitis-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skeletal Injury-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Hyperpigmentation-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Laceration-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Laceration-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Lesion-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Lesion-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Lesion-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Papilloma-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Spinal Osteoarthritis-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Squamous Cell Carcinoma-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Status Epilepticus-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Suicidal Ideation-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sunburn-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Swelling-non-SAE, Rboth, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Swelling-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Syncope-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tachycardia-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tachycardia-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Therapy Cessation-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Thrombosis-non-SAE, NR, Severe | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Thrombosis-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tinea Infection-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tongue Coated-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tonsillar Hypertrophy-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tonsillar Hypertrophy-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tooth Abscess-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tooth Abscess-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tooth Impacted-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tooth Infection-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Toothache-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tongue Injury-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tremor-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tricuspid Valve Incompetence-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tympanic Membrane Disorder-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tympanic Membrane Hyperaemia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Upper Airway Cough Syndrome-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mild | 0.080 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mod | 0.023 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urinary Tract Infection-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urinary Tract Infection-non-SAE, NR, Mod | 0.057 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urine Analysis Abnormal-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urticaria-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urticaria-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urticaria-non-SAE, RIGIV, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Uterine Polyp-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vaginal Haemorrhage-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vascular Access Complication-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vertigo-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Diarrhoea-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Infection-non-SAE, NR, Mild | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Infection-non-SAE, NR, Mod | 0.034 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Infection-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vision Blurred-non-SAE, NR, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mild | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, NR, Mild | 0.057 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, NR, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, RIGIV, Mild | 0.046 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, RIGIV, Mod | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, RIGIV, Severe | 0.011 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, Rboth, Mod | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vulvovaginal Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| Full Analysis Data Set (FADS) | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, NR, Mild | 0.034 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, RIGIV, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, NR, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Night Sweats-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema Genital-non-SAE, Rboth, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Fungal Infection-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Therapy Cessation-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Otitis Externa-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, Rboth, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urticaria-non-SAE, NR, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rales-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pneumonia Bacterial-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Thrombosis-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rales-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, NR, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash-non-SAE, NR, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rhinitis Allergic-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Road Traffic Accident-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Thrombosis-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinus Congestion-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinusitis-non-SAE, NR, Mild | 0.309 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Weight Decreased-non-SAE, RrHu, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urticaria-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Weight Decreased-non-SAE, RrHu, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Erythematous-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Wheezing-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tinea Infection-non-SAE, NR, Mild | 0.023 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | WBC Count Decreased-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Maculo-Papular-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | White Blood Cells Urine Positive-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | WBC Urine Positive-non-SAE, RIGIV Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Pustular-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Congestion-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tongue Coated-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Congestion-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Pustular-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Congestion-non-SAE, RIGIV, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urticaria-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Discomfort-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rash Papular-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Mucosal Discolouration-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tonsillar Hypertrophy-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasal Turbinate Hypertrophy-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Failure-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nasopharyngitis-non-SAE, NR, Mild | 0.099 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, NR, Mild | 0.210 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, RIGIV, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Rate Increased-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tonsillar Hypertrophy-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Tract Congestion-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nausea-non-SAE, Rboth, Mild | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Tract Infection-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Neck Pain-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Uterine Polyp-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Respiratory Tract Infection Viral-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Night Sweats-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rhinitis Allergic-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Nodule-non-SAE, Rboth, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tooth Abscess-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rhinitis Allergic-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vision Blurred-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema Peripheral-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Rhinorrhoea-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema Peripheral-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tooth Abscess-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oedema Peripheral-non-SAE, Rboth, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Scleritis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oesophagitis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vaginal Haemorrhage-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Onychomycosis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Scleritis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Candidiasis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tooth Impacted-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Scratch-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Herpes-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, RIGIV, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Herpes-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Seborrhoeic Dermatitis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Pain-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tooth Infection-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oral Pain-non-SAE, RrHu, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sicca Syndrome-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mild | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vascular Access Complication-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Oropharyngeal Pain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Toothache-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Osteoarthritis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Osteopenia-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinus Headache-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Osteopenia-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Osteoporosis-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tongue Injury-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Otitis Externa-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinusitis-non-SAE, NR, Mod | 0.321 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Otitis Media-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vertigo-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, NR, Mild | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinusitis-non-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tremor-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sinusitis-non-SAE, RIGIV, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, RIGIV, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skeletal Injury-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vulvovaginal Pruritus-non-SAE, RIGIV, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skeletal Injury-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, RIGIV, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tricuspid Valve Incompetence-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, RIGIV, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Hyperpigmentation-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, Rboth, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Diarrhoea-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pain in Extremity-non-SAE, Rboth, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Laceration-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Palpitations-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tympanic Membrane Disorder-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Papule-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Laceration-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Peptic Ulcer Haemorrhage-SAE, NR, Severe | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vitamin D Deficiency-non-SAE, NR, Mod | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Periorbital Haematoma-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Lesion-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Peripheral Nerve Injury-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tympanic Membrane Hyperaemia-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pertussis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Lesion-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Petit Mal Epilepsy-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Infection-non-SAE, NR, Mild | 0.086 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pharyngeal Erythema-non-SAE, NR, Mild | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Lesion-non-SAE, RIGIV, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pharyngitis-non-SAE, NR, Mild | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Upper Airway Cough Syndrome-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pharyngitis-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Skin Papilloma-non-SAE, NR, Mod | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pharyngitis Streptococcal-non-SAE, NR, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, RIGIV, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pneumonia-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Spinal Osteoarthritis-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pneumonia-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mild | 0.420 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Squamous Cell Carcinoma-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Post Procedural Infection-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Infection-non-SAE, NR, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Post Procedural Infection-non-SAE, NR, Mod | 0.062 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Status Epilepticus-SAE, NR, Severe | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Postictal Paralysis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Upper Resp. Tract Infection-non-SAE, NR, Mod | 0.123 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Postoperative Wound Infection-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Suicidal Ideation-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Procedural Pain-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, NR, Mild | 0.096 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Procedural Pain-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Sunburn-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Productive Cough-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urinary Tract Infection-non-SAE, NR, Mild | 0.025 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Swelling-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus-non-SAE, RIGIV, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Infection-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus-non-SAE, Rboth, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Swelling-non-SAE, Rboth, Mod | 0.037 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urinary Tract Infection-non-SAE, NR, Mod | 0.049 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pruritus Generalized-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Syncope-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pseudomonas Infection-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Vomiting-non-SAE, Rboth, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Psoriasis-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tachycardia-non-SAE, NR, Mild | 0 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, NR, Mild | 0.136 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Urine Analysis Abnormal-non-SAE, NR, Mild | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Tachycardia-non-SAE, NR, Mod | 0.012 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Pyrexia-non-SAE, RIGIV, Mild | 0.074 Number of AEs per participant |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z) | Viral Upper Resp. Tract Infection-non-SAE, NR Mild | 0.099 Number of AEs per participant |
Secondary
Rate of Days in Hospital
Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365\*400+100-3)/(400\*12)= 30.436875 days.
Time frame: Monthly, for up to 17 months
Population: Full Analysis Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Rate of Days in Hospital | 0.06 Days per month |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of Days in Hospital | 0.02 Days per month |
Secondary
Rate of Days Off School or Work
Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365\*400+100-3)/(400\*12)= 30.436875 days.
Time frame: Monthly, for up to 17 months
Population: Full Analysis Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Rate of Days Off School or Work | 0.23 Days off per month |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of Days Off School or Work | 0.28 Days off per month |
Secondary
Rate of Days on Antibiotics
Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up. Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures. The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365\*400+100-3)/(400\*12)= 30.436875 days.
Time frame: Monthly, for up to 17 months
Population: Full Analysis Data Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Data Set (FADS) | Rate of Days on Antibiotics | 3.15 Days on antibiotics per month |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of Days on Antibiotics | 1.69 Days on antibiotics per month |
Secondary
Rate of Temporally Associated AEs Per Infusion
Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion (temporally associated)
Time frame: During infusion or within 72 hours of completion of infusion
Population: Safety Analysis Data Set (SADS)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Rate of Temporally Associated AEs Per Infusion | Excluding infections | 0.25 Number of AEs per infusion |
| Full Analysis Data Set (FADS) | Rate of Temporally Associated AEs Per Infusion | Including infections | 0.25 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of Temporally Associated AEs Per Infusion | Excluding infections | 0.17 Number of AEs per infusion |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Rate of Temporally Associated AEs Per Infusion | Including infections | 0.21 Number of AEs per infusion |
Secondary
Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval).
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | 28.0 IU*days/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older | 22.6 IU*days/mL |
Secondary
Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older
Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20. Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC.
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older | 4.5 nL/IU/day |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older | 5.8 nL/IU/day |
Secondary
Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | 7.3 IU/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older | 5.0 IU/mL |
Secondary
Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | 2.3 IU/mL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older | 2.1 IU/mL |
Secondary
Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older. Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | 22.7 Days |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older | 30.4 Days |
Secondary
Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older
Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older | 0.1 Days |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older | 4.8 Days |
Secondary
Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older
Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older | 0.1 Days |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older | 5.0 Days |
Secondary
Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older
Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older
Time frame: PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.
Population: Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points: Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28\* SC- Days 1, 3, 5, 9, 14, 21, 28\* \*Measurements at Day 28 for the 4-week treatment interval only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Data Set (FADS) | Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older | 0.1 Days |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older | 5.1 Days |
Secondary
Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20
Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up
Time frame: IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit.
Population: Full Analysis Data Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | end of IV part | 9.63 g/L |
| Full Analysis Data Set (FADS) | Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | end of SC with rHuPH20 part | 9.95 g/L |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | end of IV part | 10.40 g/L |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | end of SC with rHuPH20 part | 10.70 g/L |
Secondary
Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20
Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4)
Time frame: IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit
Population: Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Full Analysis Data Set (FADS) | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 3 end of IV treatment (N=11,69) | 35.0 mg/dL |
| Full Analysis Data Set (FADS) | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 1 end of IV treatment (N=11,69) | 490.0 mg/dL |
| Full Analysis Data Set (FADS) | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 3 end of SC/rHuPH20 treatment (N=11,70) | 49.0 mg/dL |
| Full Analysis Data Set (FADS) | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 2 end of IV treatment (N=11,69) | 327.0 mg/dL |
| Full Analysis Data Set (FADS) | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 4 end of IV treatment (N=11,69) | 24.0 mg/dL |
| Full Analysis Data Set (FADS) | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 1 end of SC/rHuPH20 treatment (N=11,70) | 455.0 mg/dL |
| Full Analysis Data Set (FADS) | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 4 end of SC/rHuPH20 treatment (N=11,70) | 23.0 mg/dL |
| Full Analysis Data Set (FADS) | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 2 end of SC/rHuPH20 treatment (N=11,70) | 315.0 mg/dL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 4 end of SC/rHuPH20 treatment (N=11,70) | 15.0 mg/dL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 1 end of IV treatment (N=11,69) | 574.0 mg/dL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 1 end of SC/rHuPH20 treatment (N=11,70) | 548.0 mg/dL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 2 end of IV treatment (N=11,69) | 360.0 mg/dL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 3 end of IV treatment (N=11,69) | 32.0 mg/dL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 3 end of SC/rHuPH20 treatment (N=11,70) | 36.0 mg/dL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 4 end of IV treatment (N=11,69) | 14.0 mg/dL |
| SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up | Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 | IgG 2 end of SC/rHuPH20 treatment (N=11,70) | 339.0 mg/dL |