Trial Outcomes & Findings for Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects (NCT NCT00546871)

NCT ID: NCT00546871

Last Updated: 2021-05-19

Results Overview

Expressed as (AUC\_SC/AUC\_IV) \* 100

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 49 participants
• Primary outcome timeframe: Week 12 (IV) and week 32 or 33 (SC)
• Results posted on: 2021-05-19

Participant Flow

Recruitment was conducted in the United States at 9 study sites.

53 participants who enrolled were screened. Of these, 4 withdrew before treatment (1 death, 1 screen failure, 2 requested withdrawal)

Participant milestones

Measure	2 to <12 Years Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined "Adjusted Dose" in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows: -If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a -If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension	12 Years and Older Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined "Adjusted Dose" in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows: -If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a -If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension
Part 1 - IV Infusions of IGIV, PK STARTED	14	35
Part 1 - IV Infusions of IGIV, PK COMPLETED	13	35
Part 1 - IV Infusions of IGIV, PK NOT COMPLETED	1	0
Part 2 - Subcutaneous (SC) IGIV, PK STARTED	13	35
Part 2 - Subcutaneous (SC) IGIV, PK COMPLETED	12	32
Part 2 - Subcutaneous (SC) IGIV, PK NOT COMPLETED	1	3
Part 3a- SC IGIV Adjusted Dose, PK Based STARTED	12	32
Part 3a- SC IGIV Adjusted Dose, PK Based COMPLETED	12	32
Part 3a- SC IGIV Adjusted Dose, PK Based NOT COMPLETED	0	0
Part 3b - SC IGIV 12 Weeks STARTED	12	32
Part 3b - SC IGIV 12 Weeks COMPLETED	12	32
Part 3b - SC IGIV 12 Weeks NOT COMPLETED	0	0
Study Extension Period STARTED	10	26
Study Extension Period COMPLETED	9	25
Study Extension Period NOT COMPLETED	1	1

Reasons for withdrawal

Measure	2 to <12 Years Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined "Adjusted Dose" in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows: -If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a -If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension	12 Years and Older Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined "Adjusted Dose" in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows: -If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a -If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension
Part 1 - IV Infusions of IGIV, PK Withdrawal by Subject	1	0
Part 2 - Subcutaneous (SC) IGIV, PK Withdrawal by Subject	1	2
Part 2 - Subcutaneous (SC) IGIV, PK Family Emergency	0	1
Study Extension Period Protocol Violation	1	0
Study Extension Period Withdrawal by Subject	0	1

Baseline Characteristics

Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects

Baseline characteristics by cohort

Measure	Treated Participants n=49 Participants
Age, Customized 2 to <12 years	14 Participants n=5 Participants
Age, Customized ≥ 12 years	35 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12 (IV) and week 32 or 33 (SC)

Population: Participants, ≥12 years, with PK data in terms of AUC\[0-τ\]/week following IV administration and SC administration of IGIV, 10% at an adjusted/individually adapted dose in Study Part 3b

Expressed as (AUC_SC/AUC_IV) * 100

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=29 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage	95.2 percent Interval 92.3 to 98.2	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation

Population: Full safety data set (all participants, aged 2 to \<12 years who received any study drug)

Administration of IGIV, 10%: - Part 1 = IV administration (IV) - Parts 2, 3a, 3b = SC administration (SC)

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=14 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), Screening visit (n=14)	11.400 g/L Interval 9.64 to 16.8	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 3 week Interval, Visit 1 (n=5)	10.100 g/L Evaluable sample size was too small	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 3 week Interval, Visit 2 (n=4)	11.500 g/L Evaluable sample size was too small	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 3 week Interval, Visit 3 (n=5)	10.600 g/L Evaluable sample size was too small	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 3 week Interval, Visit 4 (n=5)	10.100 g/L Evaluable sample size was too small	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 3 week Interval, Visit 5 (n=5)	10.800 g/L Evaluable sample size was too small	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 4 week Interval, Visit 1 (n=7)	9.640 g/L Interval 7.24 to 17.4	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 4 week Interval, Visit 2 (n=9)	10.000 g/L Interval 7.23 to 12.4	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 4 week Interval, Visit 3 (n=7)	9.080 g/L Interval 6.34 to 18.5	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 1 (IV), 4 week Interval, Visit 4 (n=8)	10.500 g/L Interval 7.42 to 17.8	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 2 (SC), Visit 1 (n=12)	13.650 g/L Interval 12.3 to 16.7	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 2 (SC), Visit 5 (n=12)	12.800 g/L Interval 11.2 to 16.5	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 2 (SC), Visit 9 (n=12)	13.600 g/L Interval 10.1 to 17.1	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 3a (SC), Visit 1 (n=11)	11.200 g/L Interval 10.3 to 19.1	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 3a (SC), Visit 5 (n=11)	12.200 g/L Interval 11.5 to 20.0	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 3b (SC), Visit 1 (n=12)	11.500 g/L Interval 9.17 to 15.8	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 3b (SC), Visit 5 (n=12)	12.600 g/L Interval 10.2 to 15.2	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. Part 3b (SC), Visit 9 (n=12)	12.800 g/L Interval 10.3 to 15.9	—	—	—	—	—
Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years. End of Study (n=13)	12.300 g/L Interval 8.57 to 18.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Throughout study (1 year and 9 months)

Population: Full safety data set (all participants who received any study drug)

Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=49 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3B (SC) (n=44)	13.6 Percentage of Participants	2.3 Percentage of Participants	—	—	—	—
Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Extension (SC) (n= 36)	13.9 Percentage of Participants	0.0 Percentage of Participants	—	—	—	—
Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 2, 3A, 3B, Study Extension (n= 47)	40.4 Percentage of Participants	4.3 Percentage of Participants	—	—	—	—
Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 1 (IV) (n= 49)	18.4 Percentage of Participants	16.3 Percentage of Participants	—	—	—	—
Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 2 (SC) (n= 47)	29.8 Percentage of Participants	4.3 Percentage of Participants	—	—	—	—
Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3A (SC) (n=44)	15.9 Percentage of Participants	2.3 Percentage of Participants	—	—	—	—

PRIMARY outcome

Timeframe: Throughout study (1 year and 9 months)

Population: SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)

Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=38 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=38 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. Study Part 1 (IV) (n= 38)	23.7 Percentage of Participants	21.1 Percentage of Participants	—	—	—	—
Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. Study Part 2 (SC) (n= 36)	33.3 Percentage of Participants	5.6 Percentage of Participants	—	—	—	—
Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. Study Part 3A (SC) (n=34)	20.6 Percentage of Participants	2.9 Percentage of Participants	—	—	—	—
Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. Study Part 3B (SC) (n=34)	17.6 Percentage of Participants	2.9 Percentage of Participants	—	—	—	—
Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. Study Extension (SC) (n= 27)	14.8 Percentage of Participants	0.0 Percentage of Participants	—	—	—	—
Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped. Study Part 2, 3A, 3B, Study Extension (n= 36)	47.2 Percentage of Participants	5.6 Percentage of Participants	—	—	—	—

PRIMARY outcome

Timeframe: Throughout study (1 year and 9 months)

Population: SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)

Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=11 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=11 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 1 (IV) (n= 11)	0.0 Percentage of Participants	0.00 Percentage of Participants	—	—	—	—
Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 2 (SC) (n= 11)	18.2 Percentage of Participants	0.00 Percentage of Participants	—	—	—	—
Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3A (SC) (n=10)	0.00 Percentage of Participants	0.00 Percentage of Participants	—	—	—	—
Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3B (SC) (n=10)	0.00 Percentage of Participants	0.00 Percentage of Participants	—	—	—	—
Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Extension (SC) (n= 9)	11.1 Percentage of Participants	0.00 Percentage of Participants	—	—	—	—
Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 2, 3A, 3B, Study Extension (n= 11)	18.2 Percentage of Participants	0.00 Percentage of Participants	—	—	—	—

PRIMARY outcome

Timeframe: Throughout study (1 year and 9 months)

Population: Full safety data set (all participants who received any study drug)

Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=2501 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=2501 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 1 (IV) (n= 207 Infusions)	6.7 Percentage of Infusions Interval 3.6 to 11.3	6.2 Percentage of Infusions Interval 3.2 to 10.5	—	—	—	—
Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 2 (SC) (n= 595 Infusions)	4.2 Percentage of Infusions Interval 2.7 to 6.2	0.5 Percentage of Infusions Interval 0.1 to 1.3	—	—	—	—
Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3A (SC) (n=268 Infusions)	3.1 Percentage of Infusions Interval 1.4 to 5.8	0.4 Percentage of Infusions Interval 0.0 to 1.7	—	—	—	—
Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3B (SC) (n=538 Infusions)	1.1 Percentage of Infusions Interval 0.4 to 2.3	0.2 Percentage of Infusions Interval 0.0 to 0.8	—	—	—	—
Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Extension (SC) (n= 893 Infusions)	0.6 Percentage of Infusions Interval 0.2 to 1.2	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	—	—	—	—
Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Parts 2, 3A, 3B, & Extension (n= 2,294 Infusions)	1.9 Percentage of Infusions Interval 1.4 to 2.5	0.2 Percentage of Infusions Interval 0.1 to 0.5	—	—	—	—

PRIMARY outcome

Timeframe: Throughout study (1 year and 9 months)

Population: SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)

Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=1919 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=1919 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 1 (IV) (n= 162 Infusions)	8.7 Percentage of Infusions Interval 4.7 to 14.8	8.0 Percentage of Infusions Interval 4.2 to 13.8	—	—	—	—
Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 2 (SC) (n= 469 Infusions)	4.5 Percentage of Infusions Interval 2.8 to 6.8	0.6 Percentage of Infusions Interval 0.2 to 1.7	—	—	—	—
Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3A (SC) (n=206 Infusions)	4.0 Percentage of Infusions Interval 1.8 to 7.7	0.5 Percentage of Infusions Interval 0.0 to 2.2	—	—	—	—
Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3B (SC) (n=418 Infusions)	1.5 Percentage of Infusions Interval 0.6 to 3.0	0.2 Percentage of Infusions Interval 0.0 to 1.1	—	—	—	—
Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Extension (SC) (n= 664 Infusions)	0.6 Percentage of Infusions Interval 0.2 to 1.4	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	—	—	—	—
Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Parts 2, 3A, 3B, & Extension (n= 1,757 Infusions)	2.2 Percentage of Infusions Interval 1.6 to 3.0	0.3 Percentage of Infusions Interval 0.1 to 0.6	—	—	—	—

PRIMARY outcome

Timeframe: Throughout study (1 year and 9 months)

Population: SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)

Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=582 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=582 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 1 (IV) (n= 45 Infusions)	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	—	—	—	—
Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 2 (SC) (n= 126 Infusions)	3.3 Percentage of Infusions Interval 1.0 to 7.8	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	—	—	—	—
Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3A (SC) (n=62 Infusions)	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	—	—	—	—
Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Part 3B (SC) (n=120 Infusions)	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	—	—	—	—
Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Study Extension (SC) (n= 229 Infusions)	0.4 Percentage of Infusions Interval 0.0 to 1.9	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	—	—	—	—
Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Parts 2, 3A, 3B, & Extension (n= 537 Infusions)	0.9 Percentage of Infusions Interval 0.3 to 2.0	0.0 Percentage of Infusions There were no infusion rate changes; therefore there is no confidence interval.	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)

Maximal immune globulin concentration after infusion

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 1 (IV): Maximum Plasma Concentration (C-max)	22.7 g/L Interval 21.0 to 25.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)

Minimal immune globulin concentration after infusion

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 1 (IV): Minimum Plasma Concentration (C-min)	10.1 g/L Interval 9.4 to 12.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)

Computed as weight-adjusted dose divided by total AUC

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 1 (IV): Weight-adjusted Clearance	1.36 mL/kg/day Interval 1.23 to 1.42	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the 30-minute-post-infusion measurements 2. ≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28 3. for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)

Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50%during the terminal phase.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 1 (IV): Terminal Half-life	33.1 days Interval 28.7 to 41.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Maximal immune globulin concentration after infusion

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=31 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max)	14.5 g/L Interval 12.3 to 16.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Time to reach C-max

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=31 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max)	4.8 days Interval 3.0 to 4.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Minimal immune globulin concentration after infusion

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=31 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 2 (SC): Minimum Plasma Concentration (C-min)	12.5 g/L Interval 11.3 to 14.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Computed as weight-adjusted dose divided by total AUC

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=31 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 2 (SC): Weight-adjusted Clearance	1.86 mL/kg/day Interval 1.61 to 2.04	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Maximal immune globulin concentration after infusion

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 3B: Maximum Plasma Concentration (C-max)	14.1 g/L Interval 12.5 to 16.3	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Time to reach C-max

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max)	2.9 days Interval 1.2 to 3.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Minimal immune globulin concentration after infusion

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 3B: Minimum Plasma Concentration (C-min)	12.6 g/L Interval 10.6 to 14.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Study Parts 1, 2 and 3b, AUC(0-τ) was standardized for the infusion intervals (3 or 4 weeks vs. 1 week).

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 3B: Area Under the Curve (AUC)	94.6 g*days/L Interval 80.4 to 106.9	—	—	—	—	—

SECONDARY outcome

Timeframe: Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.

Population: Participants for whom the following PK measurements are available: 1. pre-infusion and the Day 7 measurements 2. ≥2 measurements for Days 1, 3, and 5

Computed as weight-adjusted dose divided by total AUC

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=32 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Study Part 3B: Weight-adjusted Clearance	2.00 mL/kg/day Interval 1.84 to 2.12	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation

Population: Full safety data set (all participants who received any study drug), 12 Years and Older

Part 1: IgG trough levels measured at each IV infusion day (every 3rd or 4th week depending on schedule/frequency of participants for a total of 12 weeks) Part 2: IgG trough levels measured at weeks 1, 5 and 9 (of a total of 12 weeks) Part 3a: IgG trough levels measured at weeks 1 and 5 (of a total of 6 weeks) Part 3b: IgG trough levels measured at weeks 1, 5, 9 and 12 (of a total of 12 weeks)

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=35 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 3 week Interval, Visit 4 (n=5)	11.700 g/L Evaluable sample size was too small	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 3 week Interval, Visit 5 (n=5)	12.400 g/L Evaluable sample size was too small	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 2, Visit 5 (n=34)	12.700 g/L Interval 11.6 to 15.2	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 2, Visit 9 (n=32)	12.900 g/L Interval 11.8 to 14.8	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 3a, Visit 1 (n=32)	12.850 g/L Interval 11.6 to 14.9	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 3a, Visit 5 (n=31)	13.100 g/L Interval 11.4 to 15.1	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 3b, Visit 1 (n=31)	12.900 g/L Interval 11.6 to 15.2	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 3b, Visit 5 (n=28)	13.400 g/L Interval 11.0 to 14.6	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 3b, Visit 9 (n=31)	13.600 g/L Interval 11.0 to 14.4	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older End of Study (n=34)	13.100 g/L Interval 11.3 to 14.4	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, Screening visit (n=35)	11.800 g/L Interval 10.3 to 13.0	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 3 week Interval, Visit 1 (n=4)	10.900 g/L Evaluable sample size was too small	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 3 week Interval, Visit 2 (n=4)	11.050 g/L Evaluable sample size was too small	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 3 week Interval, Visit 3 (n=5)	14.000 g/L Evaluable sample size was too small	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 4 week Interval, Visit 1 (n=29)	11.000 g/L Interval 10.0 to 12.3	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 4 week Interval, Visit 2 (n=29)	10.800 g/L Interval 9.65 to 12.5	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 4 week Interval, Visit 3 (n=30)	10.200 g/L Interval 9.48 to 12.6	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 1, 4 week Interval, Visit 4 (n=30)	10.150 g/L Interval 9.48 to 12.2	—	—	—	—	—
Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older Part 2, Visit 1 (n=35)	15.300 g/L Interval 14.8 to 17.1	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation

Population: All participants with specific antibody test results

Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, Screening visit (n=49)	2.790 µg/mL Interval 2.3 to 3.24	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 3 week Interval, Visit 1 (n=10)	2.830 µg/mL Interval 2.02 to 4.35	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 3 week Interval, Visit 2 (n=10)	2.885 µg/mL Interval 1.91 to 4.31	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 3 week Interval, Visit 3 (n=10)	3.150 µg/mL Interval 2.03 to 3.95	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 3 week Interval, Visit 4 (n=10)	3.145 µg/mL Interval 0.82 to 4.04	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 3 week Interval, Visit 5 (n=10)	3.045 µg/mL Interval 1.65 to 4.14	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 4 week Interval, Visit 1 (n=38)	2.210 µg/mL Interval 1.86 to 2.48	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 4 week Interval, Visit 2 (n=39)	2.030 µg/mL Interval 1.68 to 2.78	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 4 week Interval, Visit 3 (n=39)	2.130 µg/mL Interval 1.75 to 2.67	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 1, 4 week Interval, Visit 4 (n=38)	2.135 µg/mL Interval 2.02 to 2.61	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 2, Visit 1 (n=47)	3.280 µg/mL Interval 3.0 to 3.86	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 2, Visit 5 (n=46)	2.810 µg/mL Interval 2.36 to 3.08	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 2, Visit 9 (n=44)	3.175 µg/mL Interval 2.53 to 3.47	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 3a, Visit 1 (n=44)	2.840 µg/mL Interval 2.4 to 3.16	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 3b, Visit 1 (n=43)	3.030 µg/mL Interval 2.61 to 3.5	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 3b, Visit 5 (n=41)	3.070 µg/mL Interval 2.82 to 3.65	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Part 3b, Visit 9 (n=44)	3.285 µg/mL Interval 2.78 to 3.87	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants Extension, Visit 1 (n=36)	2.940 µg/mL Interval 2.53 to 3.78	—	—	—	—	—
Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants End of Study (n=46)	3.010 µg/mL Interval 2.66 to 3.69	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation

Population: All participants with specific antibody test results

Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 2, Visit 1 (n=46)	401.350 mIU/mL Interval 380.8 to 482.2	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 2, Visit 5 (n=46)	341.100 mIU/mL Interval 301.7 to 364.7	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 2, Visit 9 (n=44)	316.800 mIU/mL Interval 282.8 to 367.9	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 3a, Visit 1 (n=44)	318.450 mIU/mL Interval 280.2 to 351.0	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, Screening visit (n=36)	239.450 mIU/mL Interval 180.0 to 293.3	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 3 week Interval, Visit 1 (n=8)	182.050 mIU/mL Interval 139.5 to 789.0	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 3 week Interval, Visit 2 (n=10)	251.150 mIU/mL Interval 208.6 to 311.9	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 3 week Interval, Visit 3 (n=10)	282.050 mIU/mL Interval 231.9 to 333.9	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 3 week Interval, Visit 4 (n=10)	274.200 mIU/mL Interval 223.1 to 460.7	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 3 week Interval, Visit 5 (n=10)	261.850 mIU/mL Interval 233.9 to 292.4	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 4 week Interval, Visit 1 (n=36)	197.750 mIU/mL Interval 135.6 to 242.2	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 4 week Interval, Visit 2 (n=39)	213.600 mIU/mL Interval 191.0 to 282.5	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 4 week Interval, Visit 3 (n=39)	202.800 mIU/mL Interval 172.2 to 262.6	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 1, 4 week Interval, Visit 4 (n=38)	207.850 mIU/mL Interval 183.8 to 265.8	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 3b, Visit 1 (n=43)	385.200 mIU/mL Interval 304.3 to 454.3	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 3b, Visit 5 (n=41)	314.100 mIU/mL Interval 247.2 to 374.9	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Part 3b, Visit 9 (n=44)	351.050 mIU/mL Interval 292.0 to 412.2	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants Extension, Visit 1 (n=36)	328.750 mIU/mL Interval 273.1 to 368.4	—	—	—	—	—
Trough Levels of Antibody to Hepatitis B in All Study Participants End of Study (n=44)	319.600 mIU/mL Interval 297.0 to 372.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation

Population: All participants with specific antibody test results

Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, Screening visit (n=49)	2.840 IU/mL Interval 2.5 to 3.66	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 3b, Visit 1 (n=43)	3.690 IU/mL Interval 3.21 to 4.22	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 3b, Visit 5 (n=41)	3.410 IU/mL Interval 2.78 to 4.44	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 3b, Visit 9 (n=43)	3.150 IU/mL Interval 2.92 to 3.92	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 3 week Interval, Visit 1 (n=10)	3.010 IU/mL Interval 1.74 to 3.64	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 3 week Interval, Visit 2 (n=10)	3.500 IU/mL Interval 1.97 to 4.64	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 3 week Interval, Visit 3 (n=10)	3.360 IU/mL Interval 2.18 to 4.54	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 3 week Interval, Visit 4 (n=10)	3.205 IU/mL Interval 1.81 to 5.03	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 3 week Interval, Visit 5 (n=10)	3.520 IU/mL Interval 2.23 to 4.22	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 4 week Interval, Visit 1 (n=37)	2.340 IU/mL Interval 1.98 to 2.83	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 4 week Interval, Visit 2 (n=39)	2.360 IU/mL Interval 1.88 to 2.76	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 4 week Interval, Visit 3 (n=38)	2.125 IU/mL Interval 1.89 to 2.68	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 1, 4 week Interval, Visit 4 (n=36)	2.325 IU/mL Interval 1.91 to 2.8	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 2, Visit 1 (n=47)	4.310 IU/mL Interval 3.89 to 5.05	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 2, Visit 5 (n=46)	3.445 IU/mL Interval 2.92 to 4.03	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 2, Visit 9 (n=43)	3.720 IU/mL Interval 3.09 to 4.16	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Part 3a, Visit 1 (n=44)	3.090 IU/mL Interval 2.67 to 3.83	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants Extension, Visit 1 (n=36)	3.355 IU/mL Interval 2.44 to 4.48	—	—	—	—	—
Trough Levels of Antibody to Tetanus In All Study Participants End of Study (n=46)	3.860 IU/mL Interval 3.15 to 5.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation

Population: All study participants

Antibody Titers That Were Below or Above the Protective Titer Level of >1:8 for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. Participants had multiple anti-measles antibody titers measured during the study.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=654 Antibody titers IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level Anti-Measles Antibody Tests Below a Titer of >1:8	0 Antibody titers	—	—	—	—	—
Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level Anti-Measles Antibody Tests Above a Titer of >1:8	654 Antibody titers	—	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, 1 year and 9 months

Population: Full safety data set (all participants who received any study drug)

Annual rate of all infections calculated using a Poisson model to account for different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with allowance for overdispersion by deviance method. Point estimates and likelihood-ratio based 95% confidence intervals were provided. Infections as included in analysis comprised all reported AEs that were coded to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations, described as an infection by investigator, or for which anti-infective medication was prescribed.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=14 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=35 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Annual Infection Rates During Treatment Study Part 1 (IV)	5.0 Estimated infections per year Interval 2.3 to 9.3	5.2 Estimated infections per year Interval 3.6 to 7.2	—	—	—	—
Annual Infection Rates During Treatment Study Part 2 (SC)	5.6 Estimated infections per year Interval 2.7 to 10.0	4.1 Estimated infections per year Interval 2.6 to 6.1	—	—	—	—
Annual Infection Rates During Treatment Study Part 3A (SC)	3.5 Estimated infections per year Interval 1.4 to 7.1	4.6 Estimated infections per year Interval 2.6 to 7.3	—	—	—	—
Annual Infection Rates During Treatment Study Part 3B (SC)	3.9 Estimated infections per year Interval 1.6 to 7.8	3.8 Estimated infections per year Interval 2.4 to 5.8	—	—	—	—
Annual Infection Rates During Treatment Study Extension (SC)	4.0 Estimated infections per year Interval 2.4 to 6.2	3.8 Estimated infections per year Interval 2.6 to 5.3	—	—	—	—
Annual Infection Rates During Treatment Study Part 2, 3A, 3B, Study Extension (all SC)	4.3 Estimated infections per year Interval 2.8 to 6.4	4.0 Estimated infections per year Interval 3.0 to 5.2	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, 1 year and 9 months

Population: Full Safety Data Set (All study participants who received any infusions)

Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with an allowance for overdispersion by the deviance method.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=47 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS)	0.000 Estimated infections/year	0.067 Estimated infections/year	—	—	—	—

SECONDARY outcome

Timeframe: During Infusion or Within 72 Hours of Completion of Infusions

Population: All participants who received any study drug

Rate of AEs per infusion defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion ("temporally associated") divided by the total number of infusions.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=2501 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=1919 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=582 Infusions Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Rate of Temporally Associated AEs Per Infusion Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)	0.25 AEs per infusion	0.45 AEs per infusion	0.00 AEs per infusion	—	—	—
Rate of Temporally Associated AEs Per Infusion Study Part 2 (SC) (N = 595, 469, 126)	0.08 AEs per infusion	0.13 AEs per infusion	0.08 AEs per infusion	—	—	—
Rate of Temporally Associated AEs Per Infusion Total SC (N = 2294, 1757, 537)	0.08 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	—	—	—
Rate of Temporally Associated AEs Per Infusion Study Part 3a (SC) (N = 268, 206, 62)	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	—	—	—
Rate of Temporally Associated AEs Per Infusion Study Part 3b (SC) (N = 538, 418, 120)	0.08 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	—	—	—
Rate of Temporally Associated AEs Per Infusion Study Extension (SC) (N = 893, 664, 229)	0.07 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	—	—	—

SECONDARY outcome

Timeframe: Throughout the study period (1 year and 9 months)

Population: All participants who received any study drug

Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug that occur at any time during the study divided by the total number of infusions.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=2501 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=1919 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=582 Infusions Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
AEs Deemed/Judged to be Related by the Investigator Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)	0.00 AEs per infusion	0.25 AEs per infusion	0.00 AEs per infusion	—	—	—
AEs Deemed/Judged to be Related by the Investigator Study Part 2 (SC) (N = 595, 469, 126)	0.07 AEs per infusion	0.06 AEs per infusion	0.08 AEs per infusion	—	—	—
AEs Deemed/Judged to be Related by the Investigator Study Part 3a (SC) (N = 268, 206, 62)	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	—	—	—
AEs Deemed/Judged to be Related by the Investigator Study Part 3b (SC) (N = 538, 418, 120)	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	—	—	—
AEs Deemed/Judged to be Related by the Investigator Study Extension (SC) (N = 893, 664, 229)	0.00 AEs per infusion	0.03 AEs per infusion	0.00 AEs per infusion	—	—	—
AEs Deemed/Judged to be Related by the Investigator Total SC (Study Parts 2, 3A, 3B, Study Extension)	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	—	—	—

SECONDARY outcome

Timeframe: Throughout the study period (1 year and 9 months)

Population: All participants who received any study drug

Frequency of Dose Adjustments Based on IgG Trough Levels <4.5 g/L IgG, if Any, for Each Study Part. Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=38 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=11 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) Study Part 3a (SC)	0.00 ratio	0.00 ratio	0.00 ratio	—	—	—
Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) Study Part 3b (SC)	0.00 ratio	0.00 ratio	0.00 ratio	—	—	—
Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) Study Extension (SC)	0.00 ratio	0.00 ratio	0.00 ratio	—	—	—
Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) Total SC (Study Parts 2, 3A, 3B, Study Extension)	0.00 ratio	0.00 ratio	0.00 ratio	—	—	—
Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) Study Part 1 (IV)	0.00 ratio	0.00 ratio	0.00 ratio	—	—	—
Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L) Study Part 2 (SC)	0.00 ratio	0.00 ratio	0.00 ratio	—	—	—

SECONDARY outcome

Timeframe: During Infusion or Within 72 Hours of Completion of Infusions

Population: All participants who received any study drug

Proportion of Participants Reporting 1 or More Moderate or Severe AEs That Begin During Infusion or Within 72 Hours of Completion of an Infusion.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=38 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=11 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs Study Part 1 (IV)	0.43 Proportion of participants	0.47 Proportion of participants	0.27 Proportion of participants	—	—	—
Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs Study Part 2 (SC)	0.36 Proportion of participants	0.44 Proportion of participants	0.09 Proportion of participants	—	—	—
Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs Study Part 3a (SC)	0.23 Proportion of participants	0.24 Proportion of participants	0.20 Proportion of participants	—	—	—
Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs Study Part 3b (SC)	0.36 Proportion of participants	0.38 Proportion of participants	0.30 Proportion of participants	—	—	—
Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs Study Extension (SC)	0.50 Proportion of participants	0.56 Proportion of participants	0.33 Proportion of participants	—	—	—
Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs Total SC (Study Parts 2, 3A, 3B, Study Extension)	0.66 Proportion of participants	0.75 Proportion of participants	0.36 Proportion of participants	—	—	—

SECONDARY outcome

Timeframe: Throughout entire study (1 year and 9 months)

Population: All study participants who received any study drug during each of the study parts

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=47 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=44 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration n=44 Participants	Study Extension, SC Administration n=36 Participants	Total SC (Parts 2, 3a, 3b, Extension) n=47 Participants
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Discomfort- non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Distension-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	7 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Distension-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Distension-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Distension-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain Upper-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	6 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain Upper-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain Upper-non-SAE, R, Mild	0 Adverse events	3 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Tenderness-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Acne-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Acne-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Acute Sinusitis-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Addison's Disease-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Ammonia Increased-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Animal Bite-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Aphthous Stomatitis-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthralgia-non-SAE, NR, Moderate	0 Adverse events	3 Adverse events	1 Adverse events	2 Adverse events	1 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthritis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthropod Bite-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthenia-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthenia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma-non-SAE, NR, Moderate	3 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) ADHD-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Back Pain-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Back Pain-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Blepharitis-non-SAE,NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Blood Pressure Increased-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Systolic Increased-non-SAE, R, Mild	1 Adverse events	4 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Systolic Increased-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Breast Tenderness-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Breath Sounds Abnormal-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Bronchitis-non-SAE, NR, Mild	1 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Bursitis-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Candidiasis-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cardiac Murmur-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Centrl Venous Catheterisation-non-SAE, NR, Moderat	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chest Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chest Pain-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chills-non-SAE, R, Mild	7 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chills-non-SAE, R, Moderate	6 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) C.O.P.D.-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chronic Sinusitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chronic Sinusitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Confusional State-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctivitis Allergic-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctivitis Bacterial-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctivitis Infective-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctivitis Infective-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Constipation-non-SAE, NR, Mild	1 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Constipation-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Convulsion-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Convulsion-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Costochondritis-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cough-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Croup Infectious-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cryptosporidiosis Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cystitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dental Caries-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dermatitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dermatitis Contact-non-SAE, NR, Moderate	1 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Device Failure-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea-non-SAE, NR, Mild	1 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea-non-SAE, NR, Moderate	2 Adverse events	2 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea-non-SAE, R, Mild	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea Haemorrhagic-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea Infectious-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Drug Eruption-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dyspepsia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dyspnoea-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dyspnoea-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dyspnoea-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Ear Infection-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Ear Pain-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eczema-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eczema-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Epistaxis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Epistaxis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Excoriation-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Exostosis-non-SAE, NR,Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eye Infection Viral-non-SAE, NR, Moderate	3 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eye Irritation-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eye Oedema-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fall-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Haemorrhage-non-SAE, R, Mild	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Addison's Disease-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Alopecia-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Anorexia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Anxiety-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Tendonitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthralgia-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthralgia-non-SAE, R, Mild	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthralgia-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, R, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma Exercise Induced-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Back Pain-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Biliary Tract Infection Bacterial-SAE, NR, Moderat	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Blepharitis-non-SAE,NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Diastolic Decreased-non-SAE, R, Mild	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Blood Pressure Increased-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Systolic Increased-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Systolic Increased-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Bronchitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	4 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cervical Spinal Stenosis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) C.O.P.D.-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctival Hyperaemia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Contusion-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Contusion-non-SAE, R, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Costochondritis-non-SAE, NR, Severe	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cough-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Croup Infectious-non-SAE, NR, Mild	0 Adverse events	2 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dermatitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diverticulitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Ear Pain-non-SAE, NR, Mild	1 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fatigue-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fatigue-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fatigue-non-SAE, R, Mild	1 Adverse events	4 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fatigue-non-SAE, R, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Flank Pain-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Flatulence-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Flatulence-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Folliculitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fungal Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Furuncle-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastric Ulcer-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastric Ulcer-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis-non-SAE, R, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis Viral-non-SAE, NR, Mild	2 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis Viral-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Goitre-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gravitational Oedema-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Haematochezia-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Haemoglobin Decreased-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Haemorrhoids-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Head Injury-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, NR, Mild	8 Adverse events	5 Adverse events	3 Adverse events	4 Adverse events	8 Adverse events	20 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, NR, Moderate	4 Adverse events	0 Adverse events	2 Adverse events	1 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, R, Mild	19 Adverse events	6 Adverse events	1 Adverse events	2 Adverse events	8 Adverse events	17 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, R, Moderate	8 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, R, Severe	3 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Heart Rate Decreased-non-SAE, R, Mild	0 Adverse events	0 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Heart Rate Increased-non-SAE, NR, Mild	0 Adverse events	3 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Heart Rate Increased-non-SAE, R, Mild	4 Adverse events	4 Adverse events	3 Adverse events	1 Adverse events	1 Adverse events	9 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Heart Rate Increased-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Hiatus Hernia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Hordeolum-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Hyperlipidaemia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Hypoxia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Implant Site Pain-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infection-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infection-non-SAE, NR, Moderate	1 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Influenza-non-SAE, NR, Mild	1 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Influenza-non-SAE, NR, Moderate	2 Adverse events	4 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Related Reaction-non-SAE, R, Mild	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Erythema-non-SAE, R, Mild	0 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Haematoma-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Haematoma-non-SAE, R, Mild	0 Adverse events	2 Adverse events	2 Adverse events	2 Adverse events	6 Adverse events	12 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Haematoma-non-SAE, R, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Irritation-non-SAE, R, Mild	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Oedema-non-SAE, R, Mild	0 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pain-non-SAE, R, Mild	1 Adverse events	9 Adverse events	2 Adverse events	2 Adverse events	1 Adverse events	14 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pain-non-SAE, R, Moderate	0 Adverse events	5 Adverse events	1 Adverse events	2 Adverse events	0 Adverse events	8 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pruritus-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pruritus-non-SAE, R, Mild	0 Adverse events	2 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pruritus-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Rash-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Rash-non-SAE, R, Mild	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Reaction-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Swelling-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Swelling-non-SAE, R, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Vesicles-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Inguinal Mass-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Injection Site Haematoma-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Injection Site Haematoma-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Injection Site Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Insomnia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Insomnia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Intermit. Explosive Disorder-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Irritability-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Irritable Bowel Syndrome-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Joint Dislocation-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Joint Sprain-non-SAE, NR, Mild	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Joint Swelling-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Joint Swelling-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Laryngitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Laryngitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Laryngitis Viral-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lethargy-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Limb Injury-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lip Ulceration-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Livedo Reticularis-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lung Infection-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lung Infection-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lymphadenopathy-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Malaise-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Malaise-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Memory Impairment-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Middle Ear Effusion-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, R, Severe	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Mouth Ulceration-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Muscle Strain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Muscular Weakness-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Musculoskeletal Chest Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Musculoskeletal Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Musculoskeletal Pain-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Myalgia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	5 Adverse events	8 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Myalgia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Myopia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Congestion-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Congestion-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Disorder-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Mucosal Disorder-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Polyps-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasopharyngitis-non-SAE, NR, Mild	5 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	4 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasopharyngitis-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	4 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, NR, Mild	1 Adverse events	3 Adverse events	1 Adverse events	2 Adverse events	5 Adverse events	11 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, R, Mild	4 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events	1 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oedema Peripheral-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oedema Peripheral-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oral Herpes-non-SAE, NR, Mild	0 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oropharyngeal Pain-non-SAE, NR, Mild	1 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oropharyngeal Pain-non-SAE, NR, Moderate	2 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Osteomyelitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Osteopenia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Otitis Externa-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Otitis Media-non-SAE, NR, Mild	0 Adverse events	3 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Otitis Media-non-SAE, NR, Moderate	0 Adverse events	2 Adverse events	0 Adverse events	3 Adverse events	2 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain In Extremity-non-SAE, NR, Mild	3 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain In Extremity-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain In Extremity-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain In Extremity-non-SAE, R, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Paraesthesia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Paronychia-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Periorbital Oedema-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pharyngitis-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pharyngitis-non-SAE, NR, Moderate	2 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pharyngitis Streptococcal-non-SAE, NR, Moderate	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pneumonia-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pneumonia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pneumonia Bacterial-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pneumonia Streptococcal-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Procedural Pain-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pyrexia-non-SAE, NR, Mild	1 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	10 Adverse events	13 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pyrexia-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pyrexia-non-SAE, R, Mild	5 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	4 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pyrexia-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rales-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash Erythematous-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash Macular-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash Papular-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash Pruritic-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Respiratory Rate Increased-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Respir. Tract Infect. Viral-non-SAE, NR, Mild	2 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Congestion-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Disorder-non-SAE, NR, Severe	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Headache-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Headache-non-SAE, NR, Moderate	2 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinusitis-non-SAE, NR, Mild	3 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	4 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinusitis-non-SAE, NR, Moderate	7 Adverse events	4 Adverse events	6 Adverse events	5 Adverse events	3 Adverse events	18 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinusitis-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinusitis Fungal-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Skin Laceration-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Skin Lesion-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Skin Papilloma-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Skin Warm-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sports Injury-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Streptococcal Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Subcutaneous Abscess-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Suicidal Ideation-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sunburn-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Tooth Fracture-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Tooth Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Respir. Tract Infect Viral-non-SAE, NR, Moderate	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rhinitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rhinitis Allergic-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rhinorrhoea-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Road Traffic Accident-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Scleritis-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Scleritis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Scoliosis-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Congestion-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Toothache-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Tourette's Disorder-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Upper Respir. Tract Congestion-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Upper Respir. Tract Infection-non-SAE, NR, Mild	4 Adverse events	3 Adverse events	3 Adverse events	6 Adverse events	8 Adverse events	20 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Upper Respir. Tract Infect.-non-SAE, NR, Moderate	2 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Urinary Tract Infection-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Urticaria-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Urticaria-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vaginal Lesion-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vaginitis Bacterial-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Varicose Vein-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Varicose Vein-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vestibulitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Infection-non-SAE, NR, Mild	2 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Infection-non-SAE, NR, Moderate	3 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Skin Infection-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Upper Respir. Tract Infect-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Up. Respir Tract Infec-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vitamin D Deficiency-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vomiting-non-SAE, NR, Mild	2 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	4 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vomiting-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vomiting-non-SAE, R, Mild	8 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vomiting-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vulvovaginal Candidiasis-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vulvovaginal Mycotic Infection-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Wheezing-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Wound-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events

SECONDARY outcome

Timeframe: Throughout entire study (1 year and 9 months)

Population: All study participants who received any study drug during each of the study parts

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=49 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=47 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=44 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration n=44 Participants	Study Extension, SC Administration n=36 Participants	Total SC (Parts 2, 3a, 3b, Extension) n=47 Participants
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infection-non-SAE, NR, Moderate	0.20 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infection-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eczema-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Irritable Bowel Syndrome-non-SAE, NR, Moderate	0.00 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Ear Pain-non-SAE, R, Moderate	0.00 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Ear Pain-non-SAE, NR, Mild	0.25 AEs per infusion	0.06 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Ear Infection-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cough-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Croup Infectious-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Croup Infectious-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.11 AEs per infusion	0.11 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cryptosporidiosis Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cystitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dental Caries-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dermatitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dermatitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dermatitis Contact-non-SAE, NR, Moderate	0.25 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Device Failure-non-SAE, NR, Mild	0.23 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea-non-SAE, NR, Mild	0.25 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.05 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea-non-SAE, NR, Moderate	0.25 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.33 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.19 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea Haemorrhagic-non-SAE, NR,Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diarrhoea Infectious-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Diverticulitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Drug Eruption-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dyspepsia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dyspnoea-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dyspnoea-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Dyspnoea-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Implant Site Pain-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eczema-non-SAE, NR, Severe	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Epistaxis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Epistaxis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.14 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Excoriation-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Exostosis-non-SAE, NR,Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eye Infection Viral-non-SAE, NR, Moderate	0.38 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eye Irritation-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Eye Oedema-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fall-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fatigue-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.11 AEs per infusion	0.11 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fatigue-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fatigue-non-SAE, R, Mild	0.25 AEs per infusion	0.16 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.21 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fatigue-non-SAE, R, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Flank Pain-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Flatulence-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Flatulence-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Folliculitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Fungal Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Furuncle-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.12 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastric Ulcer-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastric Ulcer-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis Viral-non-SAE, NR, Mild	0.23 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gastroenteritis Viral-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Goitre-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Gravitational Oedema-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Haematochezia-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Haemoglobin Decreased-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Haemorrhoids-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Head Injury-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, NR, Mild	0.23 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.12 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, R, Mild	1.10 AEs per infusion	0.20 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.11 AEs per infusion	0.14 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, R, Moderate	0.63 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.24 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Headache-non-SAE, R, Severe	0.38 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Heart Rate Decreased-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.50 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Heart Rate Increased-non-SAE, NR, Mild	0.00 AEs per infusion	0.25 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Heart Rate Increased-non-SAE, R, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.25 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Heart Rate Increased-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Hiatus Hernia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Hordeolum-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Hyperlipidaemia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Hypoxia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Influenza-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Influenza-non-SAE, NR, Moderate	0.23 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Related Reaction-non-SAE, R, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Erythema-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Haematoma-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Haematoma-non-SAE, R, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.04 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Haematoma-non-SAE, R, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Haemorrhage-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Irritation-non-SAE, R, Mild	0.25 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Oedema-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pain-non-SAE, R, Mild	0.20 AEs per infusion	0.14 AEs per infusion	0.15 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.16 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pain-non-SAE, R, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.16 AEs per infusion	0.00 AEs per infusion	0.16 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pruritus-non-SAE, NR, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pruritus-non-SAE, R, Mild	0.00 AEs per infusion	0.15 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.16 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Pruritus-non-SAE, R, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Rash-non-SAE, NR, Mild	0.00 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Rash-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Reaction-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Discomfort- non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Distension-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.29 AEs per infusion	0.29 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Distension-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Distension-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Distension-non-SAE, R, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.11 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctivitis Allergic-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain Upper-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain Upper-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Pain Upper-non-SAE, R, Mild	0.00 AEs per infusion	0.10 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Abdominal Tenderness-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Acne-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Acne-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Acute Sinusitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Addison's Disease-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Addison's Disease-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Alopecia-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Ammonia Increased-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Animal Bite-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Anorexia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Anxiety-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Aphthous Stomatitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.14 AEs per infusion	0.14 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthralgia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.10 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.04 AEs per infusion	0.11 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthralgia-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthralgia-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthralgia-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthritis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Arthropod Bite-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthenia-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthenia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Asthma Exercise Induced-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) ADHD-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Back Pain-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Back Pain-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Back Pain-non-SAE, R, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Biliary Tract Infection Bacterial-SAE, NR, Moderat	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Blepharitis-non-SAE,NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Blepharitis-non-SAE,NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Diastolic Decreased-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.33 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.33 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Blood Pressure Increased-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Blood Pressure Increased-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Systolic Increased-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.12 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Systolic Increased-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Systolic Increased-non-SAE, R, Mild	0.25 AEs per infusion	0.16 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) B.P. Systolic Increased-non-SAE, R, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Breast Tenderness-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Breath Sounds Abnormal-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Bronchitis-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.06 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Bronchitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Bursitis-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Candidiasis-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cardiac Murmur-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Centrl Venous Catheterisation-non-SAE, NR, Moderat	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cervical Spinal Stenosis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chest Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chest Pain-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chills-non-SAE, R, Mild	0.75 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chills-non-SAE, R, Moderate	0.75 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) C.O.P.D.-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) C.O.P.D.-non-SAE, NR, Severe	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chronic Sinusitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Chronic Sinusitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Confusional State-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctival Hyperaemia-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctivitis Bacterial-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Myopia-non-SAE, NR, Mild	0.00 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctivitis Infective-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Conjunctivitis Infective-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Constipation-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Constipation-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Contusion-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Contusion-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Convulsion-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Convulsion-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Costochondritis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Costochondritis-non-SAE, NR, Severe	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Cough-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Congestion-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Congestion-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Disorder-non-SAE, NR, Severe	0.00 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Headache-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinus Headache-non-SAE, NR, Moderate	0.50 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinusitis-non-SAE, NR, Mild	0.46 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinusitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinusitis-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sinusitis Fungal-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Skin Laceration-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Skin Lesion-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Skin Papilloma-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Skin Warm-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sports Injury-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Streptococcal Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Subcutaneous Abscess-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Suicidal Ideation-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Sunburn-non-SAE, NR, Severe	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Tendonitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Tooth Fracture-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Tooth Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Toothache-non-SAE, NR, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Tourette's Disorder-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Upper Respir. Tract Congestion-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Upper Respir. Tract Infection-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.05 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Upper Respir. Tract Infect.-non-SAE, NR, Moderate	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Urinary Tract Infection-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Urticaria-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Urticaria-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vaginal Lesion-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vaginitis Bacterial-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Varicose Vein-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Varicose Vein-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vestibulitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Infection-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Infection-non-SAE, NR, Moderate	0.38 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Skin Infection-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Upper Respir. Tract Infect-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Viral Up. Respir Tract Infec-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vitamin D Deficiency-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vomiting-non-SAE, NR, Mild	0.25 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vomiting-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vomiting-non-SAE, R, Mild	0.75 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vomiting-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.18 AEs per infusion	0.00 AEs per infusion	0.18 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vulvovaginal Candidiasis-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Swelling-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Swelling-non-SAE, R, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Infusion Site Vesicles-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Inguinal Mass-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Injection Site Haematoma-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Injection Site Haematoma-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Injection Site Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Insomnia-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Insomnia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Intermit. Explosive Disorder-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Irritability-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.13 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Joint Dislocation-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Joint Sprain-non-SAE, NR, Mild	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Joint Swelling-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Joint Swelling-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Laryngitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Laryngitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Laryngitis Viral-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lethargy-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Limb Injury-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lip Ulceration-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Livedo Reticularis-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lung Infection-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lung Infection-non-SAE, NR, Severe	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Lymphadenopathy-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Malaise-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Malaise-non-SAE, R, Moderate	0.00 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Memory Impairment-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Middle Ear Effusion-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, NR, Severe	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, R, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Migraine-non-SAE, R, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Mouth Ulceration-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Muscle Strain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Muscular Weakness-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Musculoskeletal Chest Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Musculoskeletal Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Musculoskeletal Pain-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.07 AEs per infusion	0.04 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Myalgia-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.09 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Myalgia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Congestion-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Congestion-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Disorder-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Mucosal Disorder-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasal Polyps-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasopharyngitis-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nasopharyngitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.12 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, NR, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.03 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, R, Mild	0.75 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.27 AEs per infusion	0.04 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Nausea-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oedema Peripheral-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oedema Peripheral-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oral Herpes-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oropharyngeal Pain-non-SAE, NR, Mild	0.20 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Oropharyngeal Pain-non-SAE, NR, Moderate	0.23 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Osteomyelitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Osteopenia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Otitis Externa-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Otitis Media-non-SAE, NR, Mild	0.00 AEs per infusion	0.13 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Otitis Media-non-SAE, NR, Moderate	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.13 AEs per infusion	0.11 AEs per infusion	0.14 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain In Extremity-non-SAE, NR, Mild	0.38 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain In Extremity-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain In Extremity-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pain In Extremity-non-SAE, R, Severe	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Paraesthesia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Paronychia-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Periorbital Oedema-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pharyngitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pharyngitis-non-SAE, NR, Moderate	0.50 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pharyngitis Streptococcal-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pneumonia-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pneumonia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pneumonia Bacterial-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pneumonia Streptococcal-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Procedural Pain-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pyrexia-non-SAE, NR, Mild	0.25 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pyrexia-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pyrexia-non-SAE, R, Mild	0.63 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Pyrexia-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vulvovaginal Mycotic Infection-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Wheezing-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Wound-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rales-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash Erythematous-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash Macular-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash Papular-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rash Pruritic-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Respiratory Rate Increased-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Respir. Tract Infect. Viral-non-SAE, NR, Mild	0.25 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Respir. Tract Infect Viral-non-SAE, NR, Moderate	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rhinitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rhinitis Allergic-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Rhinorrhoea-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Road Traffic Accident-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Scleritis-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Scleritis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS) Scoliosis-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion

SECONDARY outcome

Timeframe: Throughout entire study (1 year and 9 months)

Population: Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=38 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=36 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=34 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration n=34 Participants	Study Extension, SC Administration n=27 Participants	Total SC (Parts 2, 3a, 3b, Extension) n=36 Participants
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rhinorrhoea-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Haemorrhoids-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Headache-non-SAE, R, Severe	3 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pain-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Fall-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Fatigue-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Fatigue-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Fatigue-non-SAE, R, Mild	1 Adverse events	3 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Fatigue-non-SAE, R, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Flank Pain-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pneumonia Streptococcal-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Fungal Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Furuncle-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Gastric Ulcer-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Oral Herpes-non-SAE, NR, Mild	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Oropharyngeal Pain-non-SAE, NR, Mild	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Oropharyngeal Pain-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Osteomyelitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Gastric Ulcer-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Gastroenteritis-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Gastroenteritis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Gastroenteritis-non-SAE, R, Mild	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Gastroenteritis Viral-non-SAE, NR, Mild	1 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Gastroenteritis Viral-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Goitre-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Gravitational Oedema-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Haematochezia-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Haemoglobin Decreased-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Head Injury-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Headache-non-SAE, NR, Mild	7 Adverse events	3 Adverse events	2 Adverse events	3 Adverse events	8 Adverse events	16 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Headache-non-SAE, NR, Moderate	4 Adverse events	0 Adverse events	2 Adverse events	1 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Headache-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Headache-non-SAE, R, Mild	19 Adverse events	4 Adverse events	1 Adverse events	2 Adverse events	8 Adverse events	15 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Headache-non-SAE, R, Moderate	8 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Heart Rate Decreased-non-SAE, R, Mild	0 Adverse events	0 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Heart Rate Increased-non-SAE, NR, Mild	0 Adverse events	3 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Heart Rate Increased-non-SAE, R, Mild	4 Adverse events	4 Adverse events	3 Adverse events	1 Adverse events	1 Adverse events	9 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Heart Rate Increased-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Hiatus Hernia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Otitis Externa-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Otitis Media-non-SAE, NR, Mild	0 Adverse events	3 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Otitis Media-non-SAE, NR, Moderate	0 Adverse events	2 Adverse events	0 Adverse events	3 Adverse events	2 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Hordeolum-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Hyperlipidaemia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Hypoxia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Implant Site Pain-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infection-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infection-non-SAE, NR, Moderate	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Influenza-non-SAE, NR, Mild	1 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pain In Extremity-non-SAE, NR, Mild	3 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pain In Extremity-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pain In Extremity-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pain In Extremity-non-SAE, R, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Paraesthesia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Paronychia-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Periorbital Oedema-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pharyngitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pharyngitis-non-SAE, NR, Moderate	2 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pharyngitis Streptococcal-non-SAE, NR, Moderate	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pneumonia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Procedural Pain-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pyrexia-non-SAE, NR, Mild	1 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	9 Adverse events	11 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pyrexia-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pyrexia-non-SAE, R, Mild	5 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	4 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Pyrexia-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rash-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rash-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rash Erythematous-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rash Macular-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rash Papular-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rash Pruritic-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Respiratory Rate Increased-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Respir. Tract Infect. Viral-non-SAE, NR, Mild	2 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Respir. Tract Infect Viral-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rhinitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Rhinitis Allergic-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Road Traffic Accident-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Scleritis-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Scleritis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Scoliosis-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinus Congestion-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinus Congestion-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinus Disorder-non-SAE, NR, Severe	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinus Headache-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinus Headache-non-SAE, NR, Moderate	2 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinusitis-non-SAE, NR, Mild	3 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinusitis-non-SAE, NR, Moderate	6 Adverse events	4 Adverse events	4 Adverse events	4 Adverse events	3 Adverse events	15 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinusitis-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sinusitis Fungal-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Skin Laceration-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Skin Lesion-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Skin Papilloma-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Skin Warm-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Streptococcal Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Subcutaneous Abscess-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Suicidal Ideation-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Sunburn-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Tendonitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Tooth Fracture-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Tooth Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Toothache-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Tourette's Disorder-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Upper Respir. Tract Congestion-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Upper Respir. Tract Infection-non-SAE, NR, Mild	2 Adverse events	3 Adverse events	3 Adverse events	5 Adverse events	7 Adverse events	18 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Upper Respir. Tract Infect.-non-SAE, NR, Moderate	1 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Urinary Tract Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Urticaria-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Urticaria-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vaginal Lesion-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vaginitis Bacterial-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Varicose Vein-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Varicose Vein-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Viral Infection-non-SAE, NR, Mild	2 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Viral Infection-non-SAE, NR, Moderate	3 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Viral Skin Infection-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Viral Upper Respir. Tract Infect-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vitamin D Deficiency-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vomiting-non-SAE, NR, Mild	1 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	4 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vomiting-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vomiting-non-SAE, R, Mild	8 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vomiting-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vulvovaginal Candidiasis-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Vulvovaginal Mycotic Infection-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Wheezing-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Conjunctival Hyperaemia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Conjunctivitis Allergic-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Conjunctivitis Infective-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Constipation-non-SAE, NR, Mild	1 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Constipation-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Contusion-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Contusion-non-SAE, R, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Convulsion-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Centrl Venous Catheterisation-non-SAE, NR, Moderat	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Cervical Spinal Stenosis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Abdominal Discomfort- non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Abdominal Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Abdominal Pain-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Abdominal Pain Upper-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Abdominal Pain Upper-non-SAE, R, Mild	0 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Acne-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Acute Sinusitis-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Alopecia-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Ammonia Increased-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Animal Bite-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Anorexia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Anxiety-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Aphthous Stomatitis-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Arthralgia-non-SAE, NR, Moderate	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Arthralgia-non-SAE, R, Mild	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Arthralgia-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Arthritis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Arthropod Bite-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Asthenia-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Asthma-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Chest Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Asthma-non-SAE, NR, Moderate	3 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Asthma-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Asthma-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Asthma Exercise Induced-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) ADHD-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Back Pain-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Back Pain-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Back Pain-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Biliary Tract Infection Bacterial-SAE, NR, Moderat	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Blepharitis-non-SAE,NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) B.P. Diastolic Decreased-non-SAE, R, Mild	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Pain-non-SAE, R, Moderate	0 Adverse events	5 Adverse events	1 Adverse events	2 Adverse events	0 Adverse events	8 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Pruritus-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Pruritus-non-SAE, R, Mild	0 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Pruritus-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Rash-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Rash-non-SAE, R, Mild	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Reaction-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Chest Pain-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Chills-non-SAE, R, Mild	7 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Chills-non-SAE, R, Moderate	6 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) C.O.P.D.-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) C.O.P.D.-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Chronic Sinusitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Blood Pressure Increased-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Blood Pressure Increased-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) B.P. Systolic Increased-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Confusional State-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Convulsion-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Cough-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Cough-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Croup Infectious-non-SAE, NR, Mild	0 Adverse events	2 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Croup Infectious-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Cryptosporidiosis Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Dental Caries-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Dermatitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Dermatitis Contact-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Device Failure-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Diarrhoea-non-SAE, NR, Mild	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Swelling-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Swelling-non-SAE, R, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) B.P. Systolic Increased-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) B.P. Systolic Increased-non-SAE, R, Mild	1 Adverse events	4 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Diarrhoea-non-SAE, NR, Moderate	1 Adverse events	2 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Vesicles-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Inguinal Mass-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Injection Site Haematoma-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Insomnia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Diarrhoea-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Diarrhoea Haemorrhagic-non-SAE, NR,Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Diarrhoea Infectious-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Diverticulitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Drug Eruption-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Dyspnoea-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Dyspnoea-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Insomnia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Intermit. Explosive Disorder-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Irritability-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Irritable Bowel Syndrome-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Joint Dislocation-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Laryngitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) B.P. Systolic Increased-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Breast Tenderness-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Bronchitis-non-SAE, NR, Mild	1 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Bronchitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Bursitis-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Candidiasis-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Ear Infection-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Laryngitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Lethargy-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Cardiac Murmur-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Limb Injury-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Lip Ulceration-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Livedo Reticularis-non-SAE, R, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Lung Infection-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Lung Infection-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Lymphadenopathy-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Ear Pain-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Ear Pain-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Eczema-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Eczema-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Epistaxis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Epistaxis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Malaise-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Excoriation-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Malaise-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Middle Ear Effusion-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Migraine-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Migraine-non-SAE, NR, Severe	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Migraine-non-SAE, R, Severe	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Mouth Ulceration-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Muscular Weakness-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Musculoskeletal Chest Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Musculoskeletal Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Musculoskeletal Pain-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Myalgia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	5 Adverse events	8 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Myalgia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Myopia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nasal Congestion-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nasal Congestion-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nasal Disorder-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nasal Mucosal Disorder-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Eye Infection Viral-non-SAE, NR, Moderate	3 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nasal Polyps-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nasopharyngitis-non-SAE, NR, Mild	3 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nasopharyngitis-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nausea-non-SAE, NR, Mild	1 Adverse events	2 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nausea-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nausea-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Nausea-non-SAE, R, Mild	4 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Oedema Peripheral-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Influenza-non-SAE, NR, Moderate	1 Adverse events	4 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	6 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Related Reaction-non-SAE, R, Mild	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Erythema-non-SAE, R, Mild	0 Adverse events	3 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Haematoma-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Haematoma-non-SAE, R, Mild	0 Adverse events	2 Adverse events	2 Adverse events	2 Adverse events	5 Adverse events	11 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Haematoma-non-SAE, R, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Haemorrhage-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Irritation-non-SAE, R, Mild	1 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Oedema-non-SAE, R, Mild	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages) Infusion Site Pain-non-SAE, R, Mild	1 Adverse events	8 Adverse events	2 Adverse events	2 Adverse events	1 Adverse events	13 Adverse events

SECONDARY outcome

Timeframe: Throughout entire study (1 year and 9 months)

Population: Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=38 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=36 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=34 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration n=34 Participants	Study Extension, SC Administration n=27 Participants	Total SC (Parts 2, 3a, 3b, Extension) n=36 Participants
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rhinorrhoea-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Road Traffic Accident-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Diarrhoea-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rash Papular-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Respir. Tract Infect. Viral-non-SAE, NR, Mild	0.25 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Respir. Tract Infect Viral-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Upper Respir. Tract Infect.-non-SAE, NR, Moderate	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vaginitis Bacterial-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Scleritis-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) C.O.P.D.-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) C.O.P.D.-non-SAE, NR, Severe	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rhinitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rhinitis Allergic-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Scleritis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Scoliosis-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinus Congestion-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinus Congestion-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinus Disorder-non-SAE, NR, Severe	0.00 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinus Headache-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinus Headache-non-SAE, NR, Moderate	0.50 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinusitis-non-SAE, NR, Mild	0.46 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinusitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinusitis-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sinusitis Fungal-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Skin Laceration-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Skin Lesion-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Skin Papilloma-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Skin Warm-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Streptococcal Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Subcutaneous Abscess-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Suicidal Ideation-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Sunburn-non-SAE, NR, Severe	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Tendonitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Tooth Fracture-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Tooth Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Toothache-non-SAE, NR, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Tourette's Disorder-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Upper Respir. Tract Congestion-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Upper Respir. Tract Infection-non-SAE, NR, Mild	0.23 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.06 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Urinary Tract Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Urticaria-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Urticaria-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vaginal Lesion-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Varicose Vein-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Varicose Vein-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Viral Infection-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Viral Infection-non-SAE, NR, Moderate	0.38 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Viral Skin Infection-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Viral Upper Respir. Tract Infect-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vitamin D Deficiency-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vomiting-non-SAE, NR, Mild	0.25 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vomiting-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vomiting-non-SAE, R, Mild	0.75 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vomiting-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.18 AEs per infusion	0.00 AEs per infusion	0.18 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vulvovaginal Candidiasis-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Vulvovaginal Mycotic Infection-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Wheezing-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Abdominal Discomfort- non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Abdominal Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Abdominal Pain-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Abdominal Pain Upper-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Abdominal Pain Upper-non-SAE, R, Mild	0.00 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Acne-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Acute Sinusitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Alopecia-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Ammonia Increased-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Animal Bite-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Anorexia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Anxiety-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Aphthous Stomatitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.14 AEs per infusion	0.14 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Arthralgia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.11 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.11 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Arthralgia-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Arthralgia-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Arthritis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Arthropod Bite-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Asthenia-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Asthma-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Asthma-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Asthma-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Asthma-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Asthma Exercise Induced-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) ADHD-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Back Pain-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Back Pain-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Back Pain-non-SAE, R, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Biliary Tract Infection Bacterial-SAE, NR, Moderat	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Blepharitis-non-SAE,NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) B.P. Diastolic Decreased-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.33 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.33 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Blood Pressure Increased-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Blood Pressure Increased-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) B.P. Systolic Increased-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.12 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) B.P. Systolic Increased-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) B.P. Systolic Increased-non-SAE, R, Mild	0.25 AEs per infusion	0.16 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) B.P. Systolic Increased-non-SAE, R, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Breast Tenderness-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Bronchitis-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.06 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Bronchitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.12 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Bursitis-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Candidiasis-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Cardiac Murmur-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Centrl Venous Catheterisation-non-SAE, NR, Moderat	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Cervical Spinal Stenosis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Chest Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Chest Pain-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Chills-non-SAE, R, Mild	0.75 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Chills-non-SAE, R, Moderate	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Chronic Sinusitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Confusional State-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Conjunctival Hyperaemia-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Conjunctivitis Allergic-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Conjunctivitis Infective-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Constipation-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Constipation-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Contusion-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Contusion-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Convulsion-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Convulsion-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Cough-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Cough-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Croup Infectious-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Croup Infectious-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.11 AEs per infusion	0.11 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Cryptosporidiosis Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Dental Caries-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Dermatitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Dermatitis Contact-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Device Failure-non-SAE, NR, Mild	0.23 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Diarrhoea-non-SAE, NR, Mild	0.25 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Diarrhoea-non-SAE, NR, Moderate	0.25 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Diarrhoea Haemorrhagic-non-SAE, NR,Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Diarrhoea Infectious-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Diverticulitis-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Drug Eruption-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Dyspnoea-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Dyspnoea-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Ear Infection-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Ear Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.06 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Ear Pain-non-SAE, R, Moderate	0.00 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Eczema-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Eczema-non-SAE, NR, Severe	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Epistaxis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Epistaxis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.14 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Excoriation-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Eye Infection Viral-non-SAE, NR, Moderate	0.38 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Fall-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Fatigue-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.11 AEs per infusion	0.11 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Fatigue-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Fatigue-non-SAE, R, Mild	0.25 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.22 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Fatigue-non-SAE, R, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Flank Pain-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Fungal Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Furuncle-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.12 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Gastroenteritis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Gastroenteritis-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Gastroenteritis Viral-non-SAE, NR, Mild	0.20 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Gastroenteritis Viral-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Goitre-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Gravitational Oedema-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Haematochezia-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Haemoglobin Decreased-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Haemorrhoids-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Head Injury-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Headache-non-SAE, NR, Mild	0.25 AEs per infusion	0.13 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Headache-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Headache-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.12 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Headache-non-SAE, R, Mild	1.10 AEs per infusion	0.23 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.11 AEs per infusion	0.18 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Headache-non-SAE, R, Moderate	0.63 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.24 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Headache-non-SAE, R, Severe	0.38 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Heart Rate Decreased-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.50 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Heart Rate Increased-non-SAE, NR, Mild	0.00 AEs per infusion	0.25 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Heart Rate Increased-non-SAE, R, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.25 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Heart Rate Increased-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Hiatus Hernia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Hordeolum-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Hyperlipidaemia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Hypoxia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Implant Site Pain-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infection-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infection-non-SAE, NR, Moderate	0.20 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Influenza-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Influenza-non-SAE, NR, Moderate	0.20 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Related Reaction-non-SAE, R, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Erythema-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Haematoma-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Haematoma-non-SAE, R, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Haematoma-non-SAE, R, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Haemorrhage-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Irritation-non-SAE, R, Mild	0.25 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Oedema-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Pain-non-SAE, R, Mild	0.20 AEs per infusion	0.14 AEs per infusion	0.15 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.16 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Pain-non-SAE, R, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.16 AEs per infusion	0.00 AEs per infusion	0.16 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Pruritus-non-SAE, NR, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Pruritus-non-SAE, R, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Pruritus-non-SAE, R, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Rash-non-SAE, NR, Mild	0.00 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Rash-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Reaction-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Swelling-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Swelling-non-SAE, R, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Infusion Site Vesicles-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Inguinal Mass-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Injection Site Haematoma-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Insomnia-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Insomnia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Intermit. Explosive Disorder-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Irritability-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.13 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Irritable Bowel Syndrome-non-SAE, NR, Moderate	0.00 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Joint Dislocation-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Laryngitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Laryngitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Lethargy-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Limb Injury-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Lip Ulceration-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Livedo Reticularis-non-SAE, R, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Lung Infection-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Lung Infection-non-SAE, NR, Severe	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Lymphadenopathy-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Malaise-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Malaise-non-SAE, R, Moderate	0.00 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Middle Ear Effusion-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Migraine-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Migraine-non-SAE, NR, Severe	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Migraine-non-SAE, R, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pneumonia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Mouth Ulceration-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pneumonia Streptococcal-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Muscular Weakness-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Musculoskeletal Chest Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Musculoskeletal Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Musculoskeletal Pain-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.07 AEs per infusion	0.04 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Myalgia-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.09 AEs per infusion	0.9 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Myalgia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Myopia-non-SAE, NR, Mild	0.00 AEs per infusion	0.10 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nasal Congestion-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nasal Congestion-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nasal Disorder-non-SAE, NR, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nasal Mucosal Disorder-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nasal Polyps-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nasopharyngitis-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nasopharyngitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.06 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nausea-non-SAE, NR, Mild	0.25 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.07 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nausea-non-SAE, NR, Moderate	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.03 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nausea-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Nausea-non-SAE, R, Mild	0.75 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.27 AEs per infusion	0.00 AEs per infusion	0.27 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Oedema Peripheral-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Oral Herpes-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Oropharyngeal Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Procedural Pain-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Oropharyngeal Pain-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.07 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Osteomyelitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Otitis Externa-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Otitis Media-non-SAE, NR, Mild	0.00 AEs per infusion	0.13 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Otitis Media-non-SAE, NR, Moderate	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.13 AEs per infusion	0.11 AEs per infusion	0.14 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pain-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pain In Extremity-non-SAE, NR, Mild	0.38 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pain In Extremity-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pain In Extremity-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pain In Extremity-non-SAE, R, Severe	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Paraesthesia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Paronychia-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Periorbital Oedema-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pharyngitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.05 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pharyngitis-non-SAE, NR, Moderate	0.50 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pharyngitis Streptococcal-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pyrexia-non-SAE, NR, Mild	0.25 AEs per infusion	0.06 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.12 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pyrexia-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pyrexia-non-SAE, R, Mild	0.63 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Pyrexia-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rash-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rash-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rash Erythematous-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.05 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rash Macular-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Rash Pruritic-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Respiratory Rate Increased-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Gastric Ulcer-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion	0.00 AEs per infusion	0.09 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Gastric Ulcer-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages) Gastroenteritis-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion

SECONDARY outcome

Timeframe: Throughout entire study (1 year and 9 months)

Population: All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=11 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=11 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=10 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration n=10 Participants	Study Extension, SC Administration n=9 Participants	Total SC (Parts 2, 3a, 3b, Extension) n=11 Participants
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Haemorrhage-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Oedema-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Pain-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Arthralgia-non-SAE, NR, Severe	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Asthenia-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Diarrhoea-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events	1 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Dyspepsia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Eye Oedema-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Joint Swelling-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pharyngitis-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Pruritus-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Injection Site Haematoma-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Injection Site Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Joint Sprain-non-SAE, NR, Mild	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Joint Swelling-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Laryngitis Viral-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Limb Injury-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Lymphadenopathy-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Discomfort- non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Distension-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	7 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Distension-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Distension-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Distension-non-SAE, R, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Pain-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Pain Upper-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	4 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Pain Upper-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Pain Upper-non-SAE, R, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Tenderness-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Acne-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Addison's Disease-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Addison's Disease-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Arthralgia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events	1 Adverse events	5 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Back Pain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Back Pain-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Blepharitis-non-SAE,NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Breath Sounds Abnormal-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Bronchitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Chronic Sinusitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Chronic Sinusitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Conjunctivitis Bacterial-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Conjunctivitis Infective-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Costochondritis-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Costochondritis-non-SAE, NR, Severe	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Cough-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Cystitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Dermatitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Dermatitis Contact-non-SAE, NR, Moderate	1 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Diarrhoea-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Diarrhoea-non-SAE, R, Mild	0 Adverse events	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Dyspnoea-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Ear Pain-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Exostosis-non-SAE, NR,Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Eye Infection Viral-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Eye Irritation-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Fatigue-non-SAE, R, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Flatulence-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Flatulence-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Folliculitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Gastroenteritis Viral-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Headache-non-SAE, NR, Mild	1 Adverse events	2 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	4 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Headache-non-SAE, R, Mild	0 Adverse events	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infection-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Influenza-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Haematoma-non-SAE, R, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Memory Impairment-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Migraine-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Migraine-non-SAE, R, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Muscle Strain-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nasal Congestion-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nasal Congestion-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nasopharyngitis-non-SAE, NR, Mild	2 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nasopharyngitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	2 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nausea-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	1 Adverse events	1 Adverse events	4 Adverse events	7 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nausea-non-SAE, R, Mild	0 Adverse events	1 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nausea-non-SAE, R, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Oedema Peripheral-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Oral Herpes-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Oropharyngeal Pain-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Oropharyngeal Pain-non-SAE, NR, Moderate	2 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Osteopenia-non-SAE, NR, Moderate	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pain In Extremity-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pharyngitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pneumonia-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pneumonia Bacterial-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pyrexia-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Rales-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Respir. Tract Infect. Viral-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Respir. Tract Infect Viral-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Sinusitis-non-SAE, NR, Mild	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Sinusitis-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	2 Adverse events	1 Adverse events	0 Adverse events	3 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Sports Injury-non-SAE, NR, Mild	0 Adverse events	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Upper Respir. Tract Infection-non-SAE, NR, Mild	2 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events	2 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Upper Respir. Tract Infect.-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Urinary Tract Infection-non-SAE, NR, Moderate	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Vestibulitis-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Viral Up. Respir Tract Infec-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Vomiting-non-SAE, NR, Mild	1 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	1 Adverse events
Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Wound-non-SAE, NR, Moderate	0 Adverse events	0 Adverse events	0 Adverse events	1 Adverse events	0 Adverse events	1 Adverse events

SECONDARY outcome

Timeframe: Throughout entire study (1 year and 9 months)

Population: All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts

Seriousness and causality are abbreviated below as: Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions.

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=11 Participants IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=11 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=10 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration n=10 Participants	Study Extension, SC Administration n=9 Participants	Total SC (Parts 2, 3a, 3b, Extension) n=11 Participants
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nausea-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nausea-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nausea-non-SAE, R, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nasopharyngitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Memory Impairment-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pain In Extremity-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pharyngitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pharyngitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pneumonia-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pneumonia Bacterial-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Pyrexia-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Rales-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Respir. Tract Infect. Viral-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Respir. Tract Infect Viral-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Sinusitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Sinusitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Sports Injury-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Upper Respir. Tract Infection-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.03 AEs per infusion	0.06 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Upper Respir. Tract Infect.-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Urinary Tract Infection-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Vestibulitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Viral Up. Respir Tract Infec-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Vomiting-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Vulvovaginal Mycotic Infect.-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Wound-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Discomfort- non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Distension-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.29 AEs per infusion	0.29 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Distension-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Distension-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Distension-non-SAE, R, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Tenderness-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Pain-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Pain Upper-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Pain Upper-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Abdominal Pain Upper-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Acne-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Addison's Disease-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Addison's Disease-non-SAE, NR, Moderate	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Arthralgia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.04 AEs per infusion	0.13 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Arthralgia-non-SAE, NR, Severe	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Asthenia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Back Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Back Pain-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Blepharitis-non-SAE,NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Breath Sounds Abnormal-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Bronchitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Chronic Sinusitis-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Chronic Sinusitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Conjunctivitis Bacterial-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Conjunctivitis Infective-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Costochondritis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Costochondritis-non-SAE, NR, Severe	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Cough-non-SAE, NR, Mild	0.50 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nasopharyngitis-non-SAE, NR, Mild	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Cystitis-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Dermatitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Dermatitis Contact-non-SAE, NR, Moderate	0.25 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Diarrhoea-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.04 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Diarrhoea-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Diarrhoea-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.33 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.33 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Dyspepsia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Dyspnoea-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Ear Pain-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Exostosis-non-SAE, NR,Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Eye Infection Viral-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Eye Irritation-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Eye Oedema-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Fatigue-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Flatulence-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Flatulence-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Folliculitis-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Gastroenteritis Viral-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Headache-non-SAE, NR, Mild	0.20 AEs per infusion	0.17 AEs per infusion	0.17 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Headache-non-SAE, R, Mild	0.00 AEs per infusion	0.16 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.16 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infection-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Influenza-non-SAE, NR, Moderate	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Haematoma-non-SAE, R, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Haemorrhage-non-SAE, R, Mild	0.00 AEs per infusion	0.07 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.07 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Oedema-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Pain-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Infusion Site Pruritus-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Injection Site Haematoma-non-SAE, R, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Injection Site Pain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Joint Sprain-non-SAE, NR, Mild	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Joint Swelling-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Joint Swelling-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Laryngitis Viral-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Limb Injury-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Lymphadenopathy-non-SAE, NR, Mild	0.25 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Migraine-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Migraine-non-SAE, R, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Muscle Strain-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.17 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.10 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nasal Congestion-non-SAE, NR, Mild	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Nasal Congestion-non-SAE, NR, Moderate	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.04 AEs per infusion	0.04 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Oedema Peripheral-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Oral Herpes-non-SAE, NR, Mild	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Oropharyngeal Pain-non-SAE, NR, Mild	0.20 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Oropharyngeal Pain-non-SAE, NR, Moderate	0.23 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.03 AEs per infusion	0.03 AEs per infusion
Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC) Osteopenia-non-SAE, NR, Moderate	0.00 AEs per infusion	0.08 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.00 AEs per infusion	0.08 AEs per infusion

SECONDARY outcome

Timeframe: Throughout the study period (1 year and 9 months)

Population: All participants who received any study drug

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=2501 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=1919 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=582 Infusions Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Infusions Associated With ≥1 AE Related to the Study Drug Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)	22.2 Percentage of infusions	27.8 Percentage of infusions	2.2 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Related to the Study Drug Study Part 2 (SC) (N = 595, 469, 126)	9.9 Percentage of infusions	10.2 Percentage of infusions	8.7 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Related to the Study Drug Study Part 3a (SC) (N = 268, 206, 62)	7.8 Percentage of infusions	8.3 Percentage of infusions	6.5 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Related to the Study Drug Study Part 3b (SC) (N = 538, 418, 120)	3.5 Percentage of infusions	4.3 Percentage of infusions	0.8 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Related to the Study Drug Study Extension (SC) (N = 893, 664, 229)	3.1 Percentage of infusions	3.8 Percentage of infusions	1.3 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Related to the Study Drug Total SC (N = 2294, 1757, 537)	5.5 Percentage of infusions	6.1 Percentage of infusions	3.5 Percentage of infusions	—	—	—

SECONDARY outcome

Timeframe: During Infusion or Within 72 Hours of Completion of Infusions

Population: All participants who received any study drug

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=2501 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=38 Participants Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=11 Participants Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion Total SC (N = 2294, 1757, 537)	10.9 Percentage of infusions	11.8 Percentage of infusions	8.2 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)	30.9 Percentage of infusions	35.8 Percentage of infusions	13.3 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion Study Part 2 (SC) (N = 595, 469, 126)	15.0 Percentage of infusions	15.8 Percentage of infusions	11.9 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion Study Part 3a (SC) (N = 268, 206, 62)	11.6 Percentage of infusions	12.6 Percentage of infusions	8.1 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion Study Part 3b (SC) (N = 538, 418, 120)	8.7 Percentage of infusions	8.9 Percentage of infusions	8.3 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion Study Extension (SC) (N = 893, 664, 229)	9.4 Percentage of infusions	10.5 Percentage of infusions	6.1 Percentage of infusions	—	—	—

SECONDARY outcome

Timeframe: During Infusion or Within 72 Hours of Completion of Infusions

Population: All participants who received any study drug

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=2501 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=1919 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=582 Infusions Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)	28.5 Percentage of infusions	32.7 Percentage of infusions	13.3 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 2 (SC) (N = 595, 469, 126)	11.8 Percentage of infusions	12.2 Percentage of infusions	10.3 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 3a (SC) (N = 268, 206, 62)	10.1 Percentage of infusions	11.2 Percentage of infusions	6.5 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 3b (SC) (N = 538, 418, 120)	7.2 Percentage of infusions	7.2 Percentage of infusions	7.5 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Extension (SC) (N = 893, 664, 229)	7.3 Percentage of infusions	8.1 Percentage of infusions	4.8 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Total SC (N = 2294, 1757, 537)	8.8 Percentage of infusions	9.3 Percentage of infusions	6.9 Percentage of infusions	—	—	—

SECONDARY outcome

Timeframe: During Infusion or Within 72 Hours of Completion of Infusions

Population: All participants who received any study drug

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=2501 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=1919 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=582 Infusions Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 3a (SC) (N = 268, 206, 62)	7.8 Percentage of infusions	8.3 Percentage of infusions	6.5 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)	28.0 Percentage of infusions	32.1 Percentage of infusions	13.3 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 2 (SC) (N = 595, 469, 126)	7.6 Percentage of infusions	7.7 Percentage of infusions	7.1 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 3b (SC) (N = 538, 418, 120)	6.1 Percentage of infusions	5.7 Percentage of infusions	7.5 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Extension (SC) (N = 893, 664, 229)	6.3 Percentage of infusions	6.9 Percentage of infusions	4.4 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Total SC (N = 2294, 1757, 537)	6.8 Percentage of infusions	7.0 Percentage of infusions	6.0 Percentage of infusions	—	—	—

SECONDARY outcome

Timeframe: During Infusion or Within 72 Hours of Completion of Infusions

Population: All participants who received any study drug

Outcome measures

Measure	Participants ≥12 Years Old With PK Data Part 1 and Part 3b n=2501 Infusions IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks). SC dosing for Study Part 3b was determined by: From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the "Adjusted Dose". Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an "Individually Adapted Dose" to ensure sufficient trough levels. Study Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was either: 1. The Adjusted Dose 2. Individually Adapted Dose	Infusion Rate Change - For Tolerability/AE n=1919 Infusions Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs	SESC n=582 Infusions Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins	Study Part 3b, SC Administration	Study Extension, SC Administration	Total SC (Parts 2, 3a, 3b, Extension)
Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 1 (IV) (Units Analyzed N= 207, 162, 45)	1.0 Percentage of infusions	1.2 Percentage of infusions	0.0 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 2 (SC) (N = 595, 469, 126)	4.9 Percentage of infusions	5.1 Percentage of infusions	4.0 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 3a (SC) (N = 268, 206, 62)	2.2 Percentage of infusions	2.9 Percentage of infusions	0.0 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Part 3b (SC) (N = 538, 418, 120)	1.5 Percentage of infusions	1.9 Percentage of infusions	0.0 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Study Extension (SC) (N = 893, 664, 229)	1.1 Percentage of infusions	1.4 Percentage of infusions	0.4 Percentage of infusions	—	—	—
Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion. Total SC (N = 2294, 1757, 537)	2.3 Percentage of infusions	2.7 Percentage of infusions	1.1 Percentage of infusions	—	—	—

Adverse Events

IV Treatment Period

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

SC Treatment Period

Serious events: 2 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Measure	IV Treatment Period n=49 participants at risk Study Part 1	SC Treatment Period n=47 participants at risk；n=48 participants at risk Study Parts 2, 3a, 3b, and Extension
Infections and infestations Sinusitis	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	0.00% 0/48 • Throughout the entire study period (1 year, 9 months)
Nervous system disorders Convulsion/seizure	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	0.00% 0/48 • Throughout the entire study period (1 year, 9 months)
Infections and infestations Biliary Tract Infection Bacterial	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	2.1% 1/48 • Number of events 1 • Throughout the entire study period (1 year, 9 months)
General disorders Chest pain	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	2.1% 1/48 • Number of events 1 • Throughout the entire study period (1 year, 9 months)

Other adverse events

Measure	IV Treatment Period n=49 participants at risk Study Part 1	SC Treatment Period n=47 participants at risk；n=48 participants at risk Study Parts 2, 3a, 3b, and Extension
Blood and lymphatic system disorders LYMPHADENOPATHY	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
Ear and labyrinth disorders EAR PAIN	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	8.5% 4/47 • Number of events 5 • Throughout the entire study period (1 year, 9 months)
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
Gastrointestinal disorders ABDOMINAL PAIN	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
Gastrointestinal disorders ABDOMINAL PAIN UPPER	2.0% 1/49 • Number of events 2 • Throughout the entire study period (1 year, 9 months)	10.6% 5/47 • Number of events 12 • Throughout the entire study period (1 year, 9 months)
Gastrointestinal disorders APHTHOUS STOMATITIS	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 4 • Throughout the entire study period (1 year, 9 months)
Gastrointestinal disorders CONSTIPATION	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 4 • Throughout the entire study period (1 year, 9 months)
Gastrointestinal disorders DIARRHOEA	6.1% 3/49 • Number of events 3 • Throughout the entire study period (1 year, 9 months)	10.6% 5/47 • Number of events 13 • Throughout the entire study period (1 year, 9 months)
Gastrointestinal disorders NAUSEA	10.2% 5/49 • Number of events 6 • Throughout the entire study period (1 year, 9 months)	17.0% 8/47 • Number of events 22 • Throughout the entire study period (1 year, 9 months)
Gastrointestinal disorders VOMITING	14.3% 7/49 • Number of events 11 • Throughout the entire study period (1 year, 9 months)	14.9% 7/47 • Number of events 12 • Throughout the entire study period (1 year, 9 months)
General disorders CHILLS	14.3% 7/49 • Number of events 13 • Throughout the entire study period (1 year, 9 months)	0.00% 0/47 • Throughout the entire study period (1 year, 9 months)
General disorders FATIGUE	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	14.9% 7/47 • Number of events 11 • Throughout the entire study period (1 year, 9 months)
General disorders INFUSION SITE ERYTHEMA	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
General disorders INFUSION SITE HAEMATOMA	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	10.6% 5/47 • Number of events 15 • Throughout the entire study period (1 year, 9 months)
General disorders INFUSION SITE OEDEMA	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
General disorders INFUSION SITE PAIN	2.0% 1/49 • Number of events 2 • Throughout the entire study period (1 year, 9 months)	21.3% 10/47 • Number of events 22 • Throughout the entire study period (1 year, 9 months)
General disorders INFUSION SITE RASH	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	8.5% 4/47 • Number of events 4 • Throughout the entire study period (1 year, 9 months)
General disorders PYREXIA	10.2% 5/49 • Number of events 8 • Throughout the entire study period (1 year, 9 months)	29.8% 14/47 • Number of events 22 • Throughout the entire study period (1 year, 9 months)
Injury, poisoning and procedural complications CONTUSION	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
Investigations BLOOD PRESSURE SYSTOLIC INCREASED	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 10 • Throughout the entire study period (1 year, 9 months)
Investigations HEART RATE INCREASED	8.2% 4/49 • Number of events 5 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 13 • Throughout the entire study period (1 year, 9 months)
Musculoskeletal and connective tissue disorders ARTHRALGIA	2.0% 1/49 • Number of events 2 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 9 • Throughout the entire study period (1 year, 9 months)
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	8.5% 4/47 • Number of events 4 • Throughout the entire study period (1 year, 9 months)
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	8.5% 4/47 • Number of events 9 • Throughout the entire study period (1 year, 9 months)
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	6.1% 3/49 • Number of events 5 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
Nervous system disorders HEADACHE	34.7% 17/49 • Number of events 42 • Throughout the entire study period (1 year, 9 months)	48.9% 23/47 • Number of events 42 • Throughout the entire study period (1 year, 9 months)
Nervous system disorders MIGRAINE	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	8.5% 4/47 • Number of events 5 • Throughout the entire study period (1 year, 9 months)
Nervous system disorders SINUS HEADACHE	4.1% 2/49 • Number of events 3 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
Psychiatric disorders INSOMNIA	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
Respiratory, thoracic and mediastinal disorders ASTHMA	6.1% 3/49 • Number of events 3 • Throughout the entire study period (1 year, 9 months)	12.8% 6/47 • Number of events 9 • Throughout the entire study period (1 year, 9 months)
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 4 • Throughout the entire study period (1 year, 9 months)
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	2.0% 1/49 • Number of events 2 • Throughout the entire study period (1 year, 9 months)	12.8% 6/47 • Number of events 8 • Throughout the entire study period (1 year, 9 months)
Skin and subcutaneous tissue disorders ECZEMA	2.0% 1/49 • Number of events 1 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 4 • Throughout the entire study period (1 year, 9 months)
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/49 • Throughout the entire study period (1 year, 9 months)	6.4% 3/47 • Number of events 3 • Throughout the entire study period (1 year, 9 months)

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

Results disclosure agreements

• Principal investigator is a sponsor employee Baxter's agreements with PIs may vary per requirements of the 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 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (e.g., for intellectual property protection)
• Publication restrictions are in place

Restriction type: OTHER