Trial Outcomes & Findings for Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy (NCT NCT00419341)

NCT ID: NCT00419341

Last Updated: 2013-01-25

Results Overview

The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

49 participants

Primary outcome timeframe

Efficacy period: up to 12 months (week 13 to the completion visit)

Results posted on

2013-01-25

Participant Flow

A total of 12 centers in the United States enrolled subjects for this study.

Participant milestones

Participant milestones
Measure	IgPro20 IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
Wash in/Wash Out Period STARTED	49
Wash in/Wash Out Period COMPLETED	38
Wash in/Wash Out Period NOT COMPLETED	11
Efficacy Period STARTED	38
Efficacy Period COMPLETED	28
Efficacy Period NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	IgPro20 IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
Wash in/Wash Out Period Withdrawal by Subject	8
Wash in/Wash Out Period Adverse Event	2
Wash in/Wash Out Period Disqualifying laboratory results	1
Efficacy Period Withdrawal by Subject	6
Efficacy Period Protocol Violation	1
Efficacy Period Lost to Follow-up	1
Efficacy Period Non-compliance	1
Efficacy Period Termination of study site	1

Baseline Characteristics

Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IgPro20 n=49 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
Age Continuous	34.4 years STANDARD_DEVIATION 20.09 • n=5 Participants
Age, Customized 2 to < 12 years	3 participants n=5 Participants
Age, Customized 12 to < 16 years	7 participants n=5 Participants
Age, Customized 16 to < 65 years	33 participants n=5 Participants
Age, Customized ≥ 65 years	6 participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants
Race/Ethnicity, Customized White	46 participants n=5 Participants
Type of Primary Immunodeficiency Common variable immunodeficiency (CVID)	46 participants 21.24 • n=5 Participants
Type of Primary Immunodeficiency X-linked agammaglobulinemia (XLA)	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to the completion visit)

Population: The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.

Outcome measures

Outcome measures
Measure	IgPro20 n=12697 Efficacy Period Subject Study Days IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)	0.00 SBIs per subject year	—

PRIMARY outcome

Timeframe: Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment

Population: The Per Protocol Pharmacokinetic (PPK) population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.

Evaluate non-inferiority of steady-state IgG area under the concentration-time curves standardized to a 7-day period (sAUCs) for subcutaneous immunoglobulin (SCIG) (IgPro20) versus the sAUC under intravenous immunoglobulin (IVIG) (Privigen) treatment. The sAUC under IVIG was taken from the same subjects in a preceding study (either ZLB03\_002CR \[NCT00168025\] or ZLB05\_006CR \[NCT00322556\]).

Outcome measures

Outcome measures
Measure	IgPro20 n=18 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) n=18 Participants Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)	105.6 days*g/L Standard Deviation 31.56	103.2 days*g/L Standard Deviation 20.00

SECONDARY outcome

Timeframe: For the duration of the study, up to 15 months

Population: The Intention To Treat (ITT) population included all subjects who were treated with IgPro20 during any study period.

The annualized rate was based on the total number of SBIs and the total number of subject study days during the study for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs.

Outcome measures

Outcome measures
Measure	IgPro20 n=16234 Subject Study Days IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Annualized Rate of Clinically Documented SBIs (ITT Population)	0.00 SBIs per subject year	—

SECONDARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to the completion visit)

Population: The Per Protocol Efficacy (PPE) population included all subjects who completed the 12-month efficacy period according to the protocol-defined requirements.

The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs.

Outcome measures

Outcome measures
Measure	IgPro20 n=9543 Efficacy Period Subject Study Days IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Annualized Rate of Clinically Documented SBIs (PPE Population)	0.00 SBIs per subject year	—

SECONDARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to completion visit)

Population: The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.

The annualized rate was based on the total number of infection episodes occurring during the efficacy period (N = 96) divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

Outcome measures

Outcome measures
Measure	IgPro20 n=12697 Subject Study Days IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Annualized Rate of Infection Episodes	2.76 infection episodes per subject year Interval 2.235 to 3.37	—

SECONDARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to the completion visit)

Population: The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.

Total number of infections for the specified analysis population

Outcome measures

Outcome measures
Measure	IgPro20 n=38 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Number of Infection Episodes (Serious and Non-serious)	96 infections	—

SECONDARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to the completion visit)

Population: The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.

The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection (N = 71), and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

Outcome measures

Outcome measures
Measure	IgPro20 n=12605 Exposure Days IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections	2.06 days per subject year	—

SECONDARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to the completion visit)

Population: The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.

Total number of days out of work / school / kindergarten / day care or unable to perform normal daily activities due to infections, for the specified analysis population

Outcome measures

Outcome measures
Measure	IgPro20 n=38 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections	71 days	—

SECONDARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to the completion visit)

Population: The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.

The annualized rate was based on the total number of days of hospitalization due to infection (N = 7) and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

Outcome measures

Outcome measures
Measure	IgPro20 n=12605 Exposure Days IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Annualized Rate of Hospitalization Due to Infection	0.20 days per subject year Interval 0.0 to 7.0	—

SECONDARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to the completion visit)

Population: The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.

Total number of days of hospitalization due to infections for the specified analysis population

Outcome measures

Outcome measures
Measure	IgPro20 n=38 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Number of Days of Hospitalization Due to Infections	7 days	—

SECONDARY outcome

Timeframe: Efficacy period: up to 12 months (week 13 to the completion visit)

Population: The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.

Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.

Outcome measures

Outcome measures
Measure	IgPro20 n=12697 Exposure Days IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Use of Antibiotics for Infection Prophylaxis and Treatment	48.52 days per subject year	—

SECONDARY outcome

Timeframe: Every 4 weeks, throughout the 12-month efficacy period

Population: The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.

The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	IgPro20 n=38 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Total Serum IgG Trough Levels	12.53 g/L Standard Deviation 3.21	—

SECONDARY outcome

Timeframe: Week 28 ± 1 week of the treatment period

Population: The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.

Outcome measures

Outcome measures
Measure	IgPro20 n=18 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Maximum Concentration (Cmax) of Total Serum IgG at Steady State	16.16 g/L Standard Deviation 4.93	—

SECONDARY outcome

Timeframe: Week 28 ± 1 week of the treatment period

Timepoint of maximum concentration (Cmax)

Outcome measures

Outcome measures
Measure	IgPro20 n=18 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Tmax at Steady State	3.118 days Full Range 1.7729 • Interval 0.0 to 6.97	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 28 ± 1 week of the treatment period

Outcome measures

Outcome measures
Measure	IgPro20 n=18 Participants IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Minimum Concentration (Cmin) of Total Serum IgG at Steady State	13.70 g/L Standard Deviation 4.39	—

OTHER_PRE_SPECIFIED outcome

Timeframe: For the duration of the study, up to 15 months

Population: The ITT population included all subjects who were treated with IgPro20 during any study period.

The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.

Outcome measures

Outcome measures
Measure	IgPro20 n=2264 Infusions IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Rate of All AEs by Relatedness and Seriousness All	0.773 AEs per infusion	—
Rate of All AEs by Relatedness and Seriousness At least possibly related	0.634 AEs per infusion	—
Rate of All AEs by Relatedness and Seriousness Serious	0.004 AEs per infusion	—
Rate of All AEs by Relatedness and Seriousness At least possibly related and serious	0 AEs per infusion	—

OTHER_PRE_SPECIFIED outcome

Timeframe: For the duration of the study, up to 15 months

Population: The ITT population included all subjects who were treated with IgPro20 during any study period.

In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of injection site reaction, injection site bruising, infusion site scab, injection site cyst, injection site eczema, injection site irritation, injection site nodule, and injection site pain. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.

Outcome measures

Outcome measures
Measure	IgPro20 n=2264 Infusions IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.	IVIG (Privigen; Previous Study) Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
Rate of Mild, Moderate, or Severe Local Reactions All	0.592 local reactions per infusion	—
Rate of Mild, Moderate, or Severe Local Reactions Mild	0.553 local reactions per infusion	—
Rate of Mild, Moderate, or Severe Local Reactions Moderate	0.038 local reactions per infusion	—
Rate of Mild, Moderate, or Severe Local Reactions Severe	0.002 local reactions per infusion	—

Adverse Events

IgPro20

Serious events: 7 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IgPro20 n=49 participants at risk IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	2.0% 1/49 • Number of events 1 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Gastroenteritis	2.0% 1/49 • Number of events 1 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Gastrointestinal disorders Small intestinal obstruction	2.0% 1/49 • Number of events 1 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
General disorders Chest pain	4.1% 2/49 • Number of events 2 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Tooth abscess	2.0% 1/49 • Number of events 1 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Cellulitis	2.0% 1/49 • Number of events 1 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Urinary tract infection	2.0% 1/49 • Number of events 1 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Investigations Haemoglobin decreased	2.0% 1/49 • Number of events 1 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	2.0% 1/49 • Number of events 1 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.

Other adverse events

Other adverse events
Measure	IgPro20 n=49 participants at risk IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
General disorders Injection site reaction	100.0% 49/49 • Number of events 1314 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Sinusitis	28.6% 14/49 • Number of events 20 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Nervous system disorders Headache	26.5% 13/49 • Number of events 40 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Nasopharyngitis	22.4% 11/49 • Number of events 15 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Respiratory, thoracic and mediastinal disorders Cough	16.3% 8/49 • Number of events 9 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Gastrointestinal disorders Diarrhoea	14.3% 7/49 • Number of events 8 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Bronchitis	12.2% 6/49 • Number of events 9 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
General disorders Fatigue	12.2% 6/49 • Number of events 6 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Gastrointestinal disorders Abdominal pain upper	10.2% 5/49 • Number of events 5 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Acute sinusitis	10.2% 5/49 • Number of events 7 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Musculoskeletal and connective tissue disorders Back pain	10.2% 5/49 • Number of events 11 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
General disorders Injection site bruising	10.2% 5/49 • Number of events 19 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Gastrointestinal disorders Nausea	10.2% 5/49 • Number of events 5 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Skin and subcutaneous tissue disorders Rash	10.2% 5/49 • Number of events 7 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Upper respiratory tract infection	10.2% 5/49 • Number of events 6 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Musculoskeletal and connective tissue disorders Arthralgia	8.2% 4/49 • Number of events 5 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.2% 4/49 • Number of events 6 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Nervous system disorders Migraine	8.2% 4/49 • Number of events 5 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
General disorders Pain	8.2% 4/49 • Number of events 5 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Musculoskeletal and connective tissue disorders Pain in extremity	8.2% 4/49 • Number of events 7 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	8.2% 4/49 • Number of events 6 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Urinary tract infection	6.1% 3/49 • Number of events 3 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Viral infection	8.2% 4/49 • Number of events 7 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Respiratory, thoracic and mediastinal disorders Asthma	6.1% 3/49 • Number of events 6 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Eye disorders Conjunctivitis	6.1% 3/49 • Number of events 3 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Injury, poisoning and procedural complications Contusion	6.1% 3/49 • Number of events 4 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Ear and labyrinth disorders Ear pain	6.1% 3/49 • Number of events 3 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Influenza	6.1% 3/49 • Number of events 3 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Psychiatric disorders Insomnia	6.1% 3/49 • Number of events 3 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Musculoskeletal and connective tissue disorders Myalgia	6.1% 3/49 • Number of events 4 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Infections and infestations Otitis media	6.1% 3/49 • Number of events 5 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.
Gastrointestinal disorders Vomiting	6.1% 3/49 • Number of events 3 • Approximately 15 months (including the 3 month wash in/wash out period and the 12 month efficacy period). For the serious AEs (SAEs), treatment-emergent SAEs are provided.

Additional Information

Clinical Trial Disclosure Manager

CSL Behring

Phone: Use email contact.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER