Trial Outcomes & Findings for Gammagard Liquid and rHuPH20 in PID (NCT NCT00814320)
NCT ID: NCT00814320
Last Updated: 2021-05-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
89 participants
Primary outcome timeframe
Throughout the study period (17 months)
Results posted on
2021-05-19
Participant Flow
Recruitment was conducted 14 clinical sites in the United States and 1 clinical site in Canada.
89 participants who enrolled were screened. Of these, 2 withdrew before treatment (both were screen failures)
Participant milestones
| Measure |
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.
|
12 Years and Older
EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%. Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study. EPOCH 2 RAMP-UP ("ramp-up"):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG. EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.
|
|---|---|---|
|
Epoch 1 (IV Treatment)
STARTED
|
14
|
73
|
|
Epoch 1 (IV Treatment)
COMPLETED
|
13
|
71
|
|
Epoch 1 (IV Treatment)
NOT COMPLETED
|
1
|
2
|
|
Between Epoch 1 (IV) and Epoch 2 Ramp-up
STARTED
|
13
|
71
|
|
Between Epoch 1 (IV) and Epoch 2 Ramp-up
COMPLETED
|
13
|
70
|
|
Between Epoch 1 (IV) and Epoch 2 Ramp-up
NOT COMPLETED
|
0
|
1
|
|
Epoch 2 Ramp-up ("Ramp-up")
STARTED
|
13
|
70
|
|
Epoch 2 Ramp-up ("Ramp-up")
COMPLETED
|
11
|
70
|
|
Epoch 2 Ramp-up ("Ramp-up")
NOT COMPLETED
|
2
|
0
|
|
Epoch 2 After Ramp-up (SC/rHuPH20)
STARTED
|
11
|
70
|
|
Epoch 2 After Ramp-up (SC/rHuPH20)
COMPLETED
|
8
|
60
|
|
Epoch 2 After Ramp-up (SC/rHuPH20)
NOT COMPLETED
|
3
|
10
|
Reasons for withdrawal
| Measure |
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.
|
12 Years and Older
EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%. Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study. EPOCH 2 RAMP-UP ("ramp-up"):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG. EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.
|
|---|---|---|
|
Epoch 1 (IV Treatment)
Withdrawal by Subject
|
1
|
0
|
|
Epoch 1 (IV Treatment)
Participant missed 2 consecutive doses
|
0
|
2
|
|
Between Epoch 1 (IV) and Epoch 2 Ramp-up
Withdrawal by Subject
|
0
|
1
|
|
Epoch 2 Ramp-up ("Ramp-up")
Adverse Event
|
1
|
0
|
|
Epoch 2 Ramp-up ("Ramp-up")
Geographic Factor
|
1
|
0
|
|
Epoch 2 After Ramp-up (SC/rHuPH20)
Adverse Event
|
1
|
4
|
|
Epoch 2 After Ramp-up (SC/rHuPH20)
Withdrawal by Subject
|
2
|
1
|
|
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
|
Baseline Characteristics
Gammagard Liquid and rHuPH20 in PID
Baseline characteristics by cohort
| Measure |
2 to <12 Years
n=14 Participants
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.
|
12 Years and Older
n=73 Participants
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.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.0 years
n=5 Participants
|
44.0 years
n=7 Participants
|
35.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=81 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
|
|---|---|---|
|
Validated Acute Serious Bacterial Infection (VASBI) Rate
|
0.025 Estimated infections/year
|
—
|
SECONDARY outcome
Timeframe: 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-infusionPopulation: 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
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=58 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
|
|---|---|---|
|
Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years
|
93.3 Percentage
Interval 91.4 to 95.2
|
—
|
SECONDARY outcome
Timeframe: 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 visitPopulation: Participants aged 2 to \< 12 years exposed to either or both study drugs with available IgG trough level measurements
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=11 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
|
|---|---|---|
|
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
Interval 97.5 to 115.4
|
—
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=73 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
|
|---|---|---|
|
Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20
Participants in Stratum A (N=19)
|
118.7 Percentage
Interval 113.6 to 124.1
|
—
|
|
Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20
Participants in Stratum B (N=54)
|
133.6 Percentage
Interval 118.3 to 150.8
|
—
|
|
Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20
Total Participants (N=73)
|
120.4 Percentage
Interval 115.5 to 125.5
|
—
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Full Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=81 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Annual Rate of All Infections Per Participant
|
4.51 Estimated infections/year
Interval 3.5 to 5.69
|
2.97 Estimated infections/year
Interval 2.51 to 3.47
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=11 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=70 Participants
|
|---|---|---|
|
Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20
end of IV part
|
9.63 g/L
Interval 8.29 to 13.6
|
10.40 g/L
Interval 9.63 to 11.4
|
|
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
Interval 7.87 to 15.0
|
10.70 g/L
Interval 9.46 to 11.8
|
SECONDARY outcome
Timeframe: 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 visitPopulation: Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements
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)
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=11 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=70 Participants
|
|---|---|---|
|
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
Interval 414.0 to 752.0
|
574.0 mg/dL
Interval 514.0 to 638.0
|
|
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
Interval 411.0 to 805.0
|
548.0 mg/dL
Interval 513.0 to 602.0
|
|
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
Interval 250.0 to 538.0
|
360.0 mg/dL
Interval 334.0 to 390.0
|
|
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
Interval 280.0 to 550.0
|
339.0 mg/dL
Interval 318.0 to 374.0
|
|
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
Interval 27.0 to 66.0
|
32.0 mg/dL
Interval 27.0 to 37.0
|
|
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
Interval 26.0 to 83.0
|
36.0 mg/dL
Interval 32.0 to 43.0
|
|
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
Interval 16.0 to 55.0
|
14.0 mg/dL
Interval 13.0 to 20.0
|
|
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
Interval 15.0 to 57.0
|
15.0 mg/dL
Interval 13.0 to 19.0
|
SECONDARY outcome
Timeframe: 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 visitPopulation: Participants in Full Analysis Data Set with available specific antibody test results
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=10 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=70 Participants
|
|---|---|---|
|
Antibody Levels to Tetanus (Clostridium Tetani Toxoid)
End of IV treatment (N=7,25)
|
2.230 IU/mL
Interval 0.064 to 4.23
|
2.320 IU/mL
Interval 1.81 to 2.71
|
|
Antibody Levels to Tetanus (Clostridium Tetani Toxoid)
End of SC/rHuPH20 treatment (N=10,70)
|
2.580 IU/mL
Interval 0.99 to 3.81
|
2.525 IU/mL
Interval 2.27 to 2.85
|
SECONDARY outcome
Timeframe: 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 visitPopulation: Participants in Full Analysis Data Set with available specific antibody test results
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=10 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=70 Participants
|
|---|---|---|
|
Antibody Levels to Haemophilus Influenzae
Influenza antibody end of IV treatment (N=7,24)
|
2.11 μg/mL
Interval 1.59 to 13.52
|
2.36 μg/mL
Interval 2.05 to 3.05
|
|
Antibody Levels to Haemophilus Influenzae
Influenza antibody end of SC treatment (N=10,70)
|
1.97 μg/mL
Interval 1.69 to 4.94
|
2.58 μg/mL
Interval 2.3 to 2.95
|
SECONDARY outcome
Timeframe: 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 visitPopulation: Participants in the Full Analysis Data Set with available specific antibody test results
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=10 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=70 Participants
|
|---|---|---|
|
Antibody Levels to Measles
Measles antibody end of IV treatment (N=0,1)
|
NA Titer
No entry in this category/arm
|
64.0 Titer
One entry in this category/arm
|
|
Antibody Levels to Measles
Measles antibody end of SC treatment (N=10,70)
|
768.0 Titer
Interval 256.0 to 2048.0
|
1024.0 Titer
Interval 512.0 to 1024.0
|
SECONDARY outcome
Timeframe: 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 visitPopulation: Participants in the Full Analysis Data Set with available specific antibody test results
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=10 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=70 Participants
|
|---|---|---|
|
Antibody Levels to Hepatitis B
Hepatitis B antibody end IV treatment (N=6,25)
|
212.9 mIU/mL
Interval 59.5 to 291.5
|
222.8 mIU/mL
Interval 190.3 to 289.4
|
|
Antibody Levels to Hepatitis B
Hepatitis B antibody end of SC treatment (N=10,70)
|
242.2 mIU/mL
Interval 125.5 to 871.9
|
249.2 mIU/mL
Interval 225.0 to 289.3
|
SECONDARY outcome
Timeframe: 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-infusionPopulation: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=68 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
|
10.1 g/L
Interval 9.5 to 10.9
|
10.4 g/L
Interval 9.4 to 11.2
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=68 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
|
93.9 g*days/L
Interval 89.1 to 102.1
|
90.5 g*days/L
Interval 83.8 to 98.4
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=68 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
IgG Clearance (CL) for Participants Aged 12 Years and Older
|
1.4 mL/kg/day
Interval 1.2 to 1.4
|
1.6 mL/kg/day
Interval 1.4 to 1.7
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=68 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
|
21.9 g/L
Interval 20.7 to 23.9
|
15.5 g/L
Interval 14.5 to 17.1
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=68 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
|
35.7 Days
Interval 32.4 to 40.4
|
45.3 Days
Interval 41.0 to 60.2
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=68 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older
|
0.1 Days
Interval 0.1 to 0.1
|
5.0 Days
Interval 3.3 to 5.1
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
|
2.3 IU/mL
Interval 2.2 to 2.7
|
2.1 IU/mL
Interval 1.9 to 2.4
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
|
28.0 IU*days/mL
Interval 27.0 to 32.2
|
22.6 IU*days/mL
Interval 19.9 to 25.6
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older
|
4.5 nL/IU/day
Interval 3.9 to 5.1
|
5.8 nL/IU/day
Interval 5.4 to 7.0
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=44 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=50 Participants
|
|---|---|---|
|
Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
|
22.7 Days
Interval 20.0 to 28.1
|
30.4 Days
Interval 25.7 to 37.2
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
|
7.3 IU/mL
Interval 6.8 to 8.1
|
5.0 IU/mL
Interval 4.4 to 5.6
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older
|
0.1 Days
Interval 0.1 to 0.2
|
5.1 Days
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older
|
2.1 μg/mL
Interval 2.0 to 2.6
|
2.2 μg/mL
Interval 1.8 to 2.6
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older
|
22.4 μg*days/mL
Interval 21.1 to 26.6
|
22.5 μg*days/mL
Interval 20.8 to 24.3
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older
|
5.8 L/kg/day
Interval 5.3 to 6.5
|
6.4 L/kg/day
Interval 5.8 to 7.1
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older
|
5.5 μg/mL
Interval 5.1 to 6.8
|
4.1 μg/mL
Interval 3.8 to 4.5
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=45 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=55 Participants
|
|---|---|---|
|
H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older
|
33.8 Days
Interval 25.6 to 45.3
|
35.0 Days
Interval 32.3 to 41.0
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=46 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=60 Participants
|
|---|---|---|
|
Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older
|
0.1 Days
Interval 0.1 to 0.2
|
4.8 Days
Interval 3.3 to 5.0
|
SECONDARY outcome
Timeframe: Monthly, for up to 17 monthsPopulation: Full Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=81 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Rate of Days Off School or Work
|
0.23 Days off per month
Interval 0.15 to 0.34
|
0.28 Days off per month
Interval 0.2 to 0.37
|
SECONDARY outcome
Timeframe: Monthly, for up to 17 monthsPopulation: Full Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=81 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Rate of Days on Antibiotics
|
3.15 Days on antibiotics per month
Interval 2.19 to 4.35
|
1.69 Days on antibiotics per month
Interval 1.29 to 2.16
|
SECONDARY outcome
Timeframe: Monthly, for up to 17 monthsPopulation: Full Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=81 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Rate of Acute Physician Visits
|
0.33 Visits per month
Interval 0.23 to 0.45
|
0.40 Visits per month
Interval 0.32 to 0.49
|
SECONDARY outcome
Timeframe: Monthly, for up to 17 monthsPopulation: Full Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=81 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Rate of Days in Hospital
|
0.06 Days per month
Interval 0.03 to 0.1
|
0.02 Days per month
Interval 0.01 to 0.03
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
9.9 Percentage of participants
|
|
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
|
4.9 Percentage of participants
|
|
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
|
1.2 Percentage of participants
|
|
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
|
84.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
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
|
1.7 Percentage of infusions
|
|
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
|
0.4 Percentage of infusions
|
|
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
|
0.2 Percentage of infusions
|
|
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
|
97.7 Percentage of infusions
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set (SADS)
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")
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
Rate of Temporally Associated AEs Per Infusion
Including infections
|
0.25 Number of AEs per infusion
Interval 0.2 to 0.5
|
0.21 Number of AEs per infusion
Interval 0.13 to 0.31
|
|
Rate of Temporally Associated AEs Per Infusion
Excluding infections
|
0.25 Number of AEs per infusion
Interval 0.2 to 0.4
|
0.17 Number of AEs per infusion
Interval 0.09 to 0.26
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set
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")
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Percentage of Participants Reporting ≥1 Temporally Associated AEs
Including infections
|
66.7 Percentage of participants
|
86.4 Percentage of participants
|
|
Percentage of Participants Reporting ≥1 Temporally Associated AEs
Excluding infections
|
63.2 Percentage of participants
|
82.7 Percentage of participants
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set
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")
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
Percentage of Infusions Resulting in ≥1 Temporally Associated AEs
Including infections
|
30.1 Percentage of infusions
|
24.5 Percentage of infusions
|
|
Percentage of Infusions Resulting in ≥1 Temporally Associated AEs
Excluding infections
|
28.8 Percentage of infusions
|
22.8 Percentage of infusions
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set
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")
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=83 Participants
|
|---|---|---|
|
Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs
Including infections
|
36.8 Percentage of participants
|
54.3 Percentage of participants
|
|
Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs
Excluding infections
|
34.5 Percentage of participants
|
46.9 Percentage of participants
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set
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")
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
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
Interval 0.0 to 0.0
|
5.9 Percentage of infusions
Interval 0.0 to 7.1
|
|
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
Interval 0.0 to 0.0
|
0.0 Percentage of infusions
Interval 0.0 to 6.3
|
SECONDARY outcome
Timeframe: During infusion or within 60 minutes of completion of the infusionPopulation: Safety Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=83 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site
|
100.0 Percentage of infusions
Interval 100.0 to 100.0
|
100.0 Percentage of infusions
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
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
Interval 20.0 to 25.0
|
8.3 Percentage of infusions
Interval 7.7 to 12.5
|
|
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
Interval 16.7 to 25.0
|
8.3 Percentage of infusions
Interval 6.3 to 10.0
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Participants exposed to either or both study drugs
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
75.3 Percentage of participants
|
|
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
|
67.9 Percentage of participants
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
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
Interval 0.0 to 0.0
|
5.9 Percentage of infusions
Interval 0.0 to 8.3
|
|
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
Interval 0.0 to 0.0
|
5.9 Percentage of infusions
Interval 0.0 to 8.3
|
SECONDARY outcome
Timeframe: At any time during the studyPopulation: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study
Including infections
|
0.0 Percentage of infusions
Interval 0.0 to 0.0
|
5.9 Percentage of infusions
Interval 0.0 to 8.3
|
|
Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study
Excluding infections
|
0.0 Percentage of infusions
Interval 0.0 to 0.0
|
5.9 Percentage of infusions
Interval 0.0 to 8.3
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion
Including infections
|
4.6 Percentage of participants
|
51.9 Percentage of participants
|
|
Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion
Excluding infections
|
4.6 Percentage of participants
|
51.9 Percentage of participants
|
SECONDARY outcome
Timeframe: During infusion or within 72 hours of completion of infusionPopulation: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
Percentage of Participants With ≥1 Local AE At Any Time During the Study
Including infections
|
5.7 Percentage of participants
|
53.1 Percentage of participants
|
|
Percentage of Participants With ≥1 Local AE At Any Time During the Study
Excluding infections
|
5.7 Percentage of participants
|
53.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
Interval 0.0 to 0.25
|
0.09 Number of AEs per participant
Interval 0.07 to 0.25
|
|
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
Interval 0.0 to 0.25
|
0.09 Number of AEs per participant
Interval 0.07 to 0.25
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
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
Interval 0.25 to 0.5
|
0.22 Number of AEs per infusion
Interval 0.13 to 0.31
|
|
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
Interval 0.2 to 0.5
|
0.18 Number of AEs per infusion
Interval 0.12 to 0.26
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
7 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
21 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
8 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
8 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
12 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
35 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
19 Number of AEs
|
|
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
|
16 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
16 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
14 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
9 Number of AEs
|
|
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
|
8 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
15 Number of AEs
|
|
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
|
8 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
20 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
8 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
11 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
6 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
8 Number of AEs
|
|
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
|
17 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
25 Number of AEs
|
|
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
|
26 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
34 Number of AEs
|
|
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
|
10 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
4 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
5 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
7 Number of AEs
|
|
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
|
3 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
8 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
1 Number of AEs
|
|
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
|
0 Number of AEs
|
|
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
|
2 Number of AEs
|
|
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
|
7 Number of AEs
|
|
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
|
3 Number of AEs
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.019 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.007 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.006 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.007 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.014 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.012 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.008 Number of AEs per infusion
|
|
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
|
0.007 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.007 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.013 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.018 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.011 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.031 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.017 Number of AEs per infusion
|
|
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
|
0.014 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.007 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.007 Number of AEs per infusion
|
|
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
|
0.015 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.010 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.005 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.022 Number of AEs per infusion
|
|
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
|
0.023 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.030 Number of AEs per infusion
|
|
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
|
0.009 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.006 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.007 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.002 Number of AEs per infusion
|
|
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
|
0.006 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.003 Number of AEs per infusion
|
|
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
|
0.004 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0.001 Number of AEs per infusion
|
|
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
|
0 Number of AEs per infusion
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.259 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.099 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.086 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.099 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.011 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.099 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.198 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.173 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.011 Number of AEs per participant
|
|
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
|
0.099 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.185 Number of AEs per participant
|
|
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
|
0.099 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.247 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.148 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.432 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.235 Number of AEs per participant
|
|
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
|
0.198 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=81 Participants
|
|---|---|---|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.099 Number of AEs per participant
|
|
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
|
0.210 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.136 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.074 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.309 Number of AEs per participant
|
|
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
|
0.321 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.023 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.420 Number of AEs per participant
|
|
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
|
0.123 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.062 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.086 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.099 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.025 Number of AEs per participant
|
|
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
|
0.096 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.037 Number of AEs per participant
|
|
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
|
0.049 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0.012 Number of AEs per participant
|
|
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
|
0 Number of AEs per participant
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs
Including infections
|
0.0 Percentage of infusions
Interval 0.0 to 25.0
|
8.3 Percentage of infusions
Interval 6.3 to 20.8
|
|
Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs
Excluding infections
|
0.0 Percentage of infusions
Interval 0.0 to 25.0
|
8.3 Percentage of infusions
Interval 6.3 to 20.8
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)
|
100.0 Percentage of infusions
Interval 100.0 to 100.0
|
100.0 Percentage of infusions
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
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.
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=365 Infusions
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
n=1129 Infusions
|
|---|---|---|
|
Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion
Including Infections
|
0.25 Percentage of AE
Interval 0.25 to 0.5
|
0.22 Percentage of AE
Interval 0.13 to 0.31
|
|
Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion
Excluding Infections
|
0.25 Percentage of AE
Interval 0.2 to 0.5
|
0.18 Percentage of AE
Interval 0.12 to 0.26
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
|
|---|---|---|
|
Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
|
0 Number of participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the study period (17 months)Population: Safety Analysis Data Set
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=81 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
|
|---|---|---|
|
Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
|
0.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
|
|---|---|---|
|
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 outcome
Timeframe: 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
Outcome measures
| Measure |
Full Analysis Data Set (FADS)
n=87 Participants
All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
|
SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up
|
|---|---|---|
|
Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis
|
0 Percentage of participants
|
—
|
Adverse Events
IV Administration of IGIV, 10%
Serious events: 3 serious events
Other events: 67 other events
Deaths: 0 deaths
SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)
Serious events: 12 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IV Administration of IGIV, 10%
n=87 participants at risk
Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.
|
SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)
n=83 participants at risk
Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up. Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.
|
|---|---|---|
|
Endocrine disorders
Adrenocortical Insufficiency Acute
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
1.1%
1/87 • Number of events 1
|
0.00%
0/83
|
|
Infections and infestations
Bronchitis
|
1.1%
1/87 • Number of events 1
|
0.00%
0/83
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Infections and infestations
Viral Infection
|
1.1%
1/87 • Number of events 1
|
0.00%
0/83
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Nervous system disorders
Petit Mal Epilepsy
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Nervous system disorders
Status Epilepticus
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
1.1%
1/87 • Number of events 1
|
1.2%
1/83 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Gastrointestinal disorders
Leukoplakia Oral
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Infections and infestations
Localised Infection
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/87
|
1.2%
1/83 • Number of events 1
|
Other adverse events
| Measure |
IV Administration of IGIV, 10%
n=87 participants at risk
Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.
|
SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)
n=83 participants at risk
Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up. Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV.
|
|---|---|---|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
2.3%
2/87 • Number of events 2
|
8.4%
7/83 • Number of events 9
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.1%
1/87 • Number of events 1
|
8.4%
7/83 • Number of events 10
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
3.4%
3/87 • Number of events 3
|
7.2%
6/83 • Number of events 11
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.0%
7/87 • Number of events 7
|
12.0%
10/83 • Number of events 15
|
|
Gastrointestinal disorders
NAUSEA
|
13.8%
12/87 • Number of events 13
|
18.1%
15/83 • Number of events 28
|
|
Gastrointestinal disorders
VOMITING
|
9.2%
8/87 • Number of events 11
|
15.7%
13/83 • Number of events 21
|
|
General disorders
CHILLS
|
8.0%
7/87 • Number of events 9
|
2.4%
2/83 • Number of events 6
|
|
General disorders
FATIGUE
|
9.2%
8/87 • Number of events 10
|
16.9%
14/83 • Number of events 25
|
|
General disorders
INFUSION SITE DISCOMFORT
|
0.00%
0/87
|
12.0%
10/83 • Number of events 33
|
|
General disorders
INFUSION SITE ERYTHEMA
|
0.00%
0/87
|
16.9%
14/83 • Number of events 47
|
|
General disorders
INFUSION SITE OEDEMA
|
0.00%
0/87
|
7.2%
6/83 • Number of events 16
|
|
General disorders
INFUSION SITE PAIN
|
1.1%
1/87 • Number of events 1
|
44.6%
37/83 • Number of events 129
|
|
General disorders
INFUSION SITE PRURITUS
|
0.00%
0/87
|
7.2%
6/83 • Number of events 21
|
|
General disorders
INFUSION SITE SWELLING
|
0.00%
0/87
|
7.2%
6/83 • Number of events 13
|
|
General disorders
LOCAL SWELLING
|
0.00%
0/87
|
6.0%
5/83 • Number of events 6
|
|
General disorders
PAIN
|
4.6%
4/87 • Number of events 4
|
8.4%
7/83 • Number of events 13
|
|
General disorders
PYREXIA
|
9.2%
8/87 • Number of events 11
|
15.7%
13/83 • Number of events 26
|
|
Infections and infestations
BRONCHITIS
|
6.9%
6/87 • Number of events 6
|
9.6%
8/83 • Number of events 12
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/87
|
6.0%
5/83 • Number of events 5
|
|
Infections and infestations
CHRONIC SINUSITIS
|
1.1%
1/87 • Number of events 1
|
6.0%
5/83 • Number of events 6
|
|
Infections and infestations
GASTROENTERITIS
|
3.4%
3/87 • Number of events 3
|
6.0%
5/83 • Number of events 5
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
3.4%
3/87 • Number of events 3
|
10.8%
9/83 • Number of events 12
|
|
Infections and infestations
INFLUENZA
|
5.7%
5/87 • Number of events 5
|
6.0%
5/83 • Number of events 6
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.6%
4/87 • Number of events 4
|
6.0%
5/83 • Number of events 10
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
1.1%
1/87 • Number of events 1
|
8.4%
7/83 • Number of events 7
|
|
Infections and infestations
SINUSITIS
|
16.1%
14/87 • Number of events 19
|
42.2%
35/83 • Number of events 59
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.2%
8/87 • Number of events 9
|
38.6%
32/83 • Number of events 49
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.9%
6/87 • Number of events 6
|
8.4%
7/83 • Number of events 7
|
|
Infections and infestations
VIRAL INFECTION
|
3.4%
3/87 • Number of events 6
|
10.8%
9/83 • Number of events 10
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
2.3%
2/87 • Number of events 2
|
8.4%
7/83 • Number of events 11
|
|
Injury, poisoning and procedural complications
CONTUSION
|
2.3%
2/87 • Number of events 2
|
7.2%
6/83 • Number of events 8
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/87
|
6.0%
5/83 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.1%
1/87 • Number of events 1
|
15.7%
13/83 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.3%
2/87 • Number of events 2
|
8.4%
7/83 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
3.4%
3/87 • Number of events 5
|
13.3%
11/83 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.6%
4/87 • Number of events 6
|
6.0%
5/83 • Number of events 9
|
|
Nervous system disorders
DIZZINESS
|
3.4%
3/87 • Number of events 3
|
13.3%
11/83 • Number of events 14
|
|
Nervous system disorders
HEADACHE
|
27.6%
24/87 • Number of events 53
|
32.5%
27/83 • Number of events 63
|
|
Nervous system disorders
MIGRAINE
|
3.4%
3/87 • Number of events 4
|
7.2%
6/83 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
8.0%
7/87 • Number of events 8
|
16.9%
14/83 • Number of events 28
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.4%
3/87 • Number of events 4
|
8.4%
7/83 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
4.6%
4/87 • Number of events 4
|
9.6%
8/83 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
2.3%
2/87 • Number of events 3
|
6.0%
5/83 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
4.6%
4/87 • Number of events 5
|
6.0%
5/83 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
1.1%
1/87 • Number of events 1
|
7.2%
6/83 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
RASH
|
2.3%
2/87 • Number of events 2
|
7.2%
6/83 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.1%
1/87 • Number of events 1
|
7.2%
6/83 • Number of events 6
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/87
|
7.2%
6/83 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Baxter's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 12 months after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥30 days prior to submission or communication. Baxter may request an additional delay of ≤60 days eg, for intellectual property protection
- Publication restrictions are in place
Restriction type: OTHER