Trial Outcomes & Findings for Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% (NCT NCT02269163)

Last Updated: 2021-11-05

Results Overview

SBIs were calculated for each subject as 52n/w, where n is the number of reported SBIs and w is the number of weeks on study. For the combined cohorts only, a 99% one-sided (upper) confidence limit for the incidence rate of SBIs (scaled to represent 12 months exposure if necessary) was derived, and the objective of demonstrating that the true infection rate was below 1 per subject per year was considered established if this upper limit was less than 1. To calculate the confidence limit, a negative binomial regression model will be used. This model includes an overdispersion parameter to account for possible intra-subject correlation as well as the actual time period each subject is on the study as an offset variable.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

82 participants

Primary outcome timeframe

One year

Results posted on

2021-11-05

Participant Flow

The term "Participants" for the overall study period reflects the number of subjects included in the analysis of the Prometic IGIV 10% Treatment period (75 subjects).

Participant milestones

Participant milestones
Measure	Cohort 1 - Adult The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 1 consisted of adult subjects aged 17-80 years.	Cohort 2 - Pediatric The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 2 consisted of pediatric subjects aged 2 to \< 17 years.
Overall Study STARTED	50	25
Overall Study COMPLETED	47	18
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 - Adult The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 1 consisted of adult subjects aged 17-80 years.	Cohort 2 - Pediatric The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 2 consisted of pediatric subjects aged 2 to \< 17 years.
Overall Study Lost to Follow-up	1	0
Overall Study Major protocol violation	0	1
Overall Study Other	2	2
Overall Study Withdrawal by Subject	0	3
Overall Study Physician Decision	0	1

Baseline Characteristics

Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 - Adult n=50 Participants The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 1 consisted of adult subjects aged 17-80 years.	Cohort 2 - Pediatric n=25 Participants The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion. Cohort 2 consisted of pediatric subjects aged 2 to \< 17 years.	Total n=75 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	9 years n=7 Participants	42.0 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	5 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	19 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	24 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Time since first Primary Immune Deficiency Disease (PIDD) diagnosis (years)	12 years n=5 Participants	1.9 years n=7 Participants	6.4 years n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: CP Treatment Period and Prometic IGIV 10% Treatment Period: Analysis was performed on the all treated population, which consisted of all subjects who are enrolled into the study and received study treatment (CP or Prometic IGIV 10%) Prometic IGIV 10% Treatment Period Cohort 1 and Cohort 2: Analysis was performed on the all treated population, which consisted of all subjects who are enrolled into the study and received study treatment

Outcome measures

Outcome measures
Measure	CP Treatment Period n=66 Participants The CP Treatment Period was the elapsed time from enrollment to the first administration of Prometic IGIV 10%; this was also known as the CP Waiting Period. During this time period, subjects received either their current CP or a CP chosen by the Investigator in consultation with their treating physician.	Prometic IGIV 10% Treatment Period n=75 Participants The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion	Prometic IGIV 10% Treatment Period (Cohort 1) n=50 Participants The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion (adult population)	Prometic IGIV 10% Treatment Period (Cohort 2) n=25 Participants The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion (pediatric population)
Annual Rate of Occurrence of Serious Bacterial Infections (SBI)	0 Rate of events per subject per year No SBIs detected	0.01 Rate of events per subject per year Interval to 0.03 No lower limit was calculated	0 Rate of events per subject per year 1-sided 99% CI calculated for combined cohorts only	0.03 Rate of events per subject per year 1-sided 99% CI calculated for combined cohorts only

SECONDARY outcome

Timeframe: One year

Subject's total IgG levels will be assessed prior to each Prometic IGIV 10% infusion

Outcome measures

Outcome measures
Measure	CP Treatment Period n=66 Participants The CP Treatment Period was the elapsed time from enrollment to the first administration of Prometic IGIV 10%; this was also known as the CP Waiting Period. During this time period, subjects received either their current CP or a CP chosen by the Investigator in consultation with their treating physician.	Prometic IGIV 10% Treatment Period n=75 Participants The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion	Prometic IGIV 10% Treatment Period (Cohort 1) n=50 Participants The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion (adult population)	Prometic IGIV 10% Treatment Period (Cohort 2) n=25 Participants The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion (pediatric population)
Trough Levels of IgG (Total) Prior to Each Prometic IGIV 10% Infusion	1075.131 mg/dL Standard Deviation 210.7547	1043.401 mg/dL Standard Deviation 208.3044	1070.725 mg/dL Standard Deviation 219.3308	988.752 mg/dL Standard Deviation 175.7991

Adverse Events

CP Treatment Period

Serious events: 5 serious events

Other events: 57 other events

Deaths: 0 deaths

Prometic IGIV 10% Treatment Period

Serious events: 7 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director, External Biologics

Prometic Biotherapeutics Inc

Phone: 438-802-3497

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of data generated in the study is governed by the Investigator Clinical Trial Agreement
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	CP Treatment Period n=66 participants at risk The CP Treatment Period was the elapsed time from enrollment to the first administration of Prometic IGIV 10%; this was also known as the CP Waiting Period. During this time period, subjects received either their current CP or a CP chosen by the Investigator in consultation with their treating physician.	Prometic IGIV 10% Treatment Period n=75 participants at risk The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion.
Infections and infestations Bacteremia	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	2.7% 2/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Gastroenteritis	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	0.00% 0/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Pneumonia	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	0.00% 0/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Influenza	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Sepsis	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Investigations False positive investigation result	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Surgical and medical procedures Adrenalectomy	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Surgical and medical procedures Knee arthroplasty	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Nervous system disorders Aphasia	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Injury, poisoning and procedural complications Upper limb fracture	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	0.00% 0/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Injury, poisoning and procedural complications Muscle strain	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	0.00% 0/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	0.00% 0/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
General disorders Chest discomfort	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	1.3% 1/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit

Other adverse events
Measure	CP Treatment Period n=66 participants at risk The CP Treatment Period was the elapsed time from enrollment to the first administration of Prometic IGIV 10%; this was also known as the CP Waiting Period. During this time period, subjects received either their current CP or a CP chosen by the Investigator in consultation with their treating physician.	Prometic IGIV 10% Treatment Period n=75 participants at risk The Prometic IGIV 10% Treatment Period was the elapsed time from the first administration of Prometic IGIV 10% to study completion.
Blood and lymphatic system disorders Lymphadenopathy	3.0% 2/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Gastrointestinal disorders Abdominal pain	3.0% 2/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Gastrointestinal disorders Abdominal pain upper	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Gastrointestinal disorders Diarrhoea	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	12.0% 9/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Gastrointestinal disorders Nausea	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	10.7% 8/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Gastrointestinal disorders Vomiting	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	10.7% 8/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
General disorders Chest pain	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
General disorders Fatigue	4.5% 3/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	22.7% 17/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
General disorders Local swelling	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
General disorders Pain	4.5% 3/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
General disorders Pyrexia	4.5% 3/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	21.3% 16/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Acute sinusitis	4.5% 3/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	13.3% 10/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Bronchitis	6.1% 4/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	8.0% 6/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Conjunctivitis	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Ear infection	3.0% 2/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	9.3% 7/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Gastroenteritis viral	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	8.0% 6/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Influenza	4.5% 3/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	8.0% 6/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Nasopharyngitis	6.1% 4/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	10.7% 8/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Pharyngitis	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Sinusitis	21.2% 14/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	21.3% 16/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Upper respiratory tract infection	19.7% 13/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	24.0% 18/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Urinary tract infection	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	10.7% 8/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Infections and infestations Viral upper respiratory tract infection	6.1% 4/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	6.7% 5/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Injury, poisoning and procedural complications Fall	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	8.0% 6/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Injury, poisoning and procedural complications Procedural headache	3.0% 2/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	10.7% 8/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Injury, poisoning and procedural complications Procedural pain	3.0% 2/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	6.7% 5/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 3/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	9.3% 7/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Musculoskeletal and connective tissue disorders Back pain	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	16.0% 12/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Nervous system disorders Dizziness	7.6% 5/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	9.3% 7/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Nervous system disorders Headache	16.7% 11/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	32.0% 24/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Nervous system disorders Migraine	3.0% 2/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	6.7% 5/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Nervous system disorders Paraesthesia	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Nervous system disorders Sinus headache	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Psychiatric disorders Anxiety	6.1% 4/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	0.00% 0/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Renal and urinary disorders Haemosiderinuria	7.6% 5/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	0.00% 0/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Respiratory, thoracic and mediastinal disorders Asthma	6.1% 4/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Respiratory, thoracic and mediastinal disorders Cough	12.1% 8/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	28.0% 21/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/66 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit	5.3% 4/75 • Adverse events (AEs) were captured from the signing of informed consent/assent to 21 ± 4 days or 28 ± 4 days following the last infusion of study drug, an average of approximately 1 year per participant. Treatment-emergent adverse events (TEAEs) are presented for the safety population which consisted of all subjects who were enrolled into the study and recceived study product (Prometic IGIV 10% or CP). At each visit, AEs were elicited using a standard non-leading question such as "How have you been since the last visit / during the previous study period?" AEs were also elicited through the use of Subject Diary cards that the Investigator reviewed in detail with the subject at each visit