Trial Outcomes & Findings for Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID) (NCT NCT00322556)

Last Updated: 2012-10-26

Results Overview

AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

55 participants

Primary outcome timeframe

During each infusion, and within 48 or 72 hours after the end of each infusion.

Results posted on

2012-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	IgPro10 A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
Overall Study STARTED	55
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	IgPro10 A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	3
Overall Study Other Reason	7

Baseline Characteristics

Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IgPro10 n=55 Participants A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
Age Continuous	30 years STANDARD_DEVIATION 21 • n=5 Participants
Age, Customized 3 to < 12 years	13 participants n=5 Participants
Age, Customized 12 to < 16 years	8 participants n=5 Participants
Age, Customized 16 to < 65 years	30 participants n=5 Participants
Age, Customized >= 65 years	4 participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: During each infusion, and within 48 or 72 hours after the end of each infusion.

Population: The Safety Data Set (SDS) comprised all subjects treated with the study drug.

AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.

Outcome measures

Outcome measures
Measure	IgPro10 n=771 Infusions A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). During infusion	0.073 Proportion of infusions	—	—
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). Within 48 hours after infusion	0.141 Proportion of infusions	—	—
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). Within 72 hours after infusion	0.150 Proportion of infusions	—	—

PRIMARY outcome

Timeframe: Within 72 hours after each infusion

Population: 'New subjects' could receive IgPro10 at up to 4 mg/kg/min. 'Old' subjects (ie, those treated with the study drug who participated in a preceding, pivotal, Phase III clinical study with intravenous IgPro10 \[study number ZLB03\_002CR, NCT00168025\]), could receive IgPro10 at up to 12 mg/kg/min at the discretion of the Investigator.

The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and \> 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.

Outcome measures

Outcome measures
Measure	IgPro10 n=81 Infusions A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) n=423 Infusions A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) n=265 Infusions A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
Influence of Infusion Rate on Temporally-Associated AEs All temporally-associated AEs	23 Infusions	153 Infusions	30 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Headache	10 Infusions	54 Infusions	2 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Pyrexia	0 Infusions	9 Infusions	1 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Nausea	0 Infusions	8 Infusions	2 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Back pain	0 Infusions	8 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Chills	0 Infusions	7 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Pain	0 Infusions	6 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Anaemia	1 Infusions	0 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Constipation	2 Infusions	0 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Fatigue	3 Infusions	0 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Influenza like illness	3 Infusions	1 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Myalgia	1 Infusions	0 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Pharyngolaryngeal pain	1 Infusions	1 Infusions	2 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Eczema	1 Infusions	0 Infusions	0 Infusions
Influence of Infusion Rate on Temporally-Associated AEs Night sweats	1 Infusions	0 Infusions	0 Infusions

PRIMARY outcome

Timeframe: For the duration of the study, up to approximately 29 months

Population: The SDS comprised all subjects treated with the study drug.

The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.

Outcome measures

Outcome measures
Measure	IgPro10 n=771 infusions A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
Rate of AEs by Severity and Relationship All mild AEs	0.467 AEs per infusion	—	—
Rate of AEs by Severity and Relationship All moderate AEs	0.280 AEs per infusion	—	—
Rate of AEs by Severity and Relationship All severe AEs	0.058 AEs per infusion	—	—
Rate of AEs by Severity and Relationship Unrelated AEs	0.610 AEs per infusion	—	—
Rate of AEs by Severity and Relationship Possibly related AEs	0.088 AEs per infusion	—	—
Rate of AEs by Severity and Relationship Probably related AEs	0.048 AEs per infusion	—	—
Rate of AEs by Severity and Relationship Related AEs	0.060 AEs per infusion	—	—
Rate of AEs by Severity and Relationship At least possibly related mild AEs	0.121 AEs per infusion	—	—
Rate of AEs by Severity and Relationship At least possibly related moderate AEs	0.062 AEs per infusion	—	—
Rate of AEs by Severity and Relationship At least possibly related severe AEs	0.013 AEs per infusion	—	—
Rate of AEs by Severity and Relationship Unrelated mild AEs	0.346 AEs per infusion	—	—
Rate of AEs by Severity and Relationship Unrelated moderate AEs	0.218 AEs per infusion	—	—
Rate of AEs by Severity and Relationship Unrelated severe AEs	0.045 AEs per infusion	—	—

PRIMARY outcome

Timeframe: Before, during, and after each infusion.

Population: The Safety Data Set (SDS) comprised all subjects treated with the study drug.

Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.

Outcome measures

Outcome measures
Measure	IgPro10 n=55 Participants A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
Number of Subjects With Clinically Significant Changes in Vital Signs.	0 Participants	—	—

SECONDARY outcome

Timeframe: For the duration of the study, up to approximately 29 months

Population: The Intention-To-Treat (ITT) data set comprised all subjects treated with the study drug

The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess.

Outcome measures

Outcome measures
Measure	IgPro10 n=20757 Subject Study Days A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
Annualized Rate of Acute Serious Bacterial Infections.	0.018 Infections per subject year	—	—

SECONDARY outcome

Timeframe: For the duration of the study, up to approximately 29 months.

Population: The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.

Outcome measures

Outcome measures
Measure	IgPro10 n=54 Participants A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.	8.5 Days Interval 0.0 to 104.0	—	—

SECONDARY outcome

Timeframe: For the duration of the study, up to approximately 29 months

Outcome measures

Outcome measures
Measure	IgPro10 n=54 Participants A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
Number of Days of Hospitalization.	0.0 Days Interval 0.0 to 17.0	—	—

SECONDARY outcome

Timeframe: For the duration of the study, up to approximately 29 months.

Population: The ITT data set comprised all subjects treated with the study drug.

The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations" and AEs with the preferred term "conjunctivitis".

Outcome measures

Outcome measures
Measure	IgPro10 n=20757 Subject Study Days A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
Annualized Rate of Any Infection.	1.600 Infections per subject year	—	—

SECONDARY outcome

Timeframe: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.

Population: The ITT data set comprised all subjects treated with the study drug for which serum IgG information was available.

Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.

Outcome measures

Outcome measures
Measure	IgPro10 n=54 Participants A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.	IgPro10 (≤ 8 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.	IgPro10 (> 8 to ≤ 12 mg/kg/Min) A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (\> 8 and ≤ 12 mg/kg/min) for old subjects.
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.	9.72 g/L Interval 5.72 to 18.01	—	—

Adverse Events

IgPro10

Serious events: 11 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IgPro10 n=55 participants at risk A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
Infections and infestations Clostridial infection	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Surgical and medical procedures Ileostomy closure	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Gastrointestinal hemorrhage	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Small intestinal obstruction	1.8% 1/55 • Number of events 2 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Intestinal obstruction	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Blood and lymphatic system disorders Splenomegaly	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Giardiasis	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Pneumonia	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Sinusitis	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Cellulitis	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Skin and subcutaneous tissue disorders Angioedema	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Psychiatric disorders Aggression	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Nervous system disorders Transient ischemic attack	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Otitis externa fungal	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Musculoskeletal and connective tissue disorders Joint effusion	1.8% 1/55 • Number of events 1 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.

Other adverse events

Other adverse events
Measure	IgPro10 n=55 participants at risk A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
Nervous system disorders Headache	38.2% 21/55 • Number of events 147 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Sinusitis	25.5% 14/55 • Number of events 15 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Respiratory, thoracic and mediastinal disorders Cough	21.8% 12/55 • Number of events 17 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Nausea	20.0% 11/55 • Number of events 16 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Diarrhea	18.2% 10/55 • Number of events 13 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	16.4% 9/55 • Number of events 11 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
General disorders Pyrexia	14.5% 8/55 • Number of events 22 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Vomiting	14.5% 8/55 • Number of events 12 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Musculoskeletal and connective tissue disorders Back pain	10.9% 6/55 • Number of events 12 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Skin and subcutaneous tissue disorders Eczema	10.9% 6/55 • Number of events 6 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Skin and subcutaneous tissue disorders Rash	10.9% 6/55 • Number of events 7 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Upper respiratory tract infection	10.9% 6/55 • Number of events 6 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 5/55 • Number of events 9 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
General disorders Fatigue	9.1% 5/55 • Number of events 9 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Nasopharyngitis	9.1% 5/55 • Number of events 5 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
General disorders Pain	9.1% 5/55 • Number of events 10 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Nervous system disorders Dizziness	7.3% 4/55 • Number of events 4 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Vascular disorders Hypertension	7.3% 4/55 • Number of events 6 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Psychiatric disorders Insomnia	7.3% 4/55 • Number of events 4 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Pneumonia	5.5% 3/55 • Number of events 3 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	7.3% 4/55 • Number of events 5 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Abdominal pain	5.5% 3/55 • Number of events 4 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Abdominal pain upper	5.5% 3/55 • Number of events 5 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Respiratory, thoracic and mediastinal disorders Asthma	5.5% 3/55 • Number of events 4 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Bronchitis	5.5% 3/55 • Number of events 3 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
General disorders Chest pain	5.5% 3/55 • Number of events 4 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
General disorders Chills	5.5% 3/55 • Number of events 7 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Eye disorders Conjunctivitis	5.5% 3/55 • Number of events 3 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Ear and labyrinth disorders Ear pain	5.5% 3/55 • Number of events 4 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Infections and infestations Gastroenteritis viral	5.5% 3/55 • Number of events 5 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
General disorders Influenza-like illness	5.5% 3/55 • Number of events 9 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Injury, poisoning and procedural complications Joint sprain	5.5% 3/55 • Number of events 5 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Injury, poisoning and procedural complications Procedural pain	5.5% 3/55 • Number of events 3 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Gastrointestinal disorders Toothache	5.5% 3/55 • Number of events 3 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
Skin and subcutaneous tissue disorders Urticaria	5.5% 3/55 • Number of events 4 • For the duration of the study, up to approximately 29 months Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.

Additional Information

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