Trial Outcomes & Findings for Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID) (NCT NCT03033745)
NCT ID: NCT03033745
Last Updated: 2020-03-25
Results Overview
A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level (\[ie, 2-7 times per week\], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
At the end of 4 weeks for each planned infusion parameter
Results posted on
2020-03-25
Participant Flow
Participant milestones
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
16
|
|
Overall Study
COMPLETED
|
14
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
Baseline characteristics by cohort
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
n=15 Participants
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
n=18 Participants
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
n=16 Participants
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 14.18 • n=93 Participants
|
26.7 years
STANDARD_DEVIATION 24.52 • n=4 Participants
|
47.9 years
STANDARD_DEVIATION 13.28 • n=27 Participants
|
40.5 years
STANDARD_DEVIATION 20.97 • n=483 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=93 Participants
|
0 participants
n=4 Participants
|
6 participants
n=27 Participants
|
9 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
18 participants
n=4 Participants
|
10 participants
n=27 Participants
|
40 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: At the end of 4 weeks for each planned infusion parameterPopulation: The Safety Analysis Set (SAS) comprised all subjects in the Full Analysis Set who received ≥ 1 dose or a partial dose of IgPro20 in the study.
A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level (\[ie, 2-7 times per week\], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level.
Outcome measures
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
n=15 Participants
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
n=18 Participants
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
n=16 Participants
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Percentage of Responders
25 ml
|
86.7 percentage of responders
|
—
|
—
|
|
Percentage of Responders
40 ml
|
73.3 percentage of responders
|
—
|
—
|
|
Percentage of Responders
50 ml
|
73.3 percentage of responders
|
—
|
—
|
|
Percentage of Responders
25 ml/h
|
—
|
77.8 percentage of responders
|
—
|
|
Percentage of Responders
50 ml/h
|
—
|
77.8 percentage of responders
|
—
|
|
Percentage of Responders
75 ml/h
|
—
|
66.7 percentage of responders
|
—
|
|
Percentage of Responders
100 ml/h
|
—
|
61.1 percentage of responders
|
—
|
|
Percentage of Responders
30 ml/h
|
—
|
—
|
100.0 percentage of responders
|
|
Percentage of Responders
60 ml/h
|
—
|
—
|
100.0 percentage of responders
|
|
Percentage of Responders
120 ml/h
|
—
|
—
|
87.5 percentage of responders
|
SECONDARY outcome
Timeframe: At the end of 4 weeks for each planned infusion parameterPopulation: SAS
Adverse event rate per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Only events are included which start prior to subject's start date of non-response.
Outcome measures
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
n=152 Infusions
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
n=222 Infusions
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
n=626 Infusions
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
25 ml
|
0.183 Number of TEAEs/infusion
|
—
|
—
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
40 ml
|
0.188 Number of TEAEs/infusion
|
—
|
—
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
50 ml
|
0.023 Number of TEAEs/infusion
|
—
|
—
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
25 ml/h
|
—
|
0.329 Number of TEAEs/infusion
|
—
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
50 ml/h
|
—
|
0.255 Number of TEAEs/infusion
|
—
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
75 ml/h
|
—
|
0.140 Number of TEAEs/infusion
|
—
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
100 ml/h
|
—
|
0.085 Number of TEAEs/infusion
|
—
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
30 ml/h
|
—
|
—
|
0.064 Number of TEAEs/infusion
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
60 ml/h
|
—
|
—
|
0.111 Number of TEAEs/infusion
|
|
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
120 ml/h
|
—
|
—
|
0.081 Number of TEAEs/infusion
|
SECONDARY outcome
Timeframe: At the end of 4 weeks for each planned infusion parameterPopulation: SAS
Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC (Not Elsewhere Classified)", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response.
Outcome measures
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
n=152 Infusions
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
n=222 Infusions
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
n=626 Infusions
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Rate of Local TEAEs Per Infusion
25 ml
|
0.150 Number of local TEAEs/infusion
|
—
|
—
|
|
Rate of Local TEAEs Per Infusion
40 ml
|
0.063 Number of local TEAEs/infusion
|
—
|
—
|
|
Rate of Local TEAEs Per Infusion
50 ml
|
0.0 Number of local TEAEs/infusion
|
—
|
—
|
|
Rate of Local TEAEs Per Infusion
25 ml/h
|
—
|
0.286 Number of local TEAEs/infusion
|
—
|
|
Rate of Local TEAEs Per Infusion
50 ml/h
|
—
|
0.145 Number of local TEAEs/infusion
|
—
|
|
Rate of Local TEAEs Per Infusion
75 ml/h
|
—
|
0.040 Number of local TEAEs/infusion
|
—
|
|
Rate of Local TEAEs Per Infusion
100 ml/h
|
—
|
0.021 Number of local TEAEs/infusion
|
—
|
|
Rate of Local TEAEs Per Infusion
30 ml/h
|
—
|
—
|
0.027 Number of local TEAEs/infusion
|
|
Rate of Local TEAEs Per Infusion
60 ml/h
|
—
|
—
|
0.082 Number of local TEAEs/infusion
|
|
Rate of Local TEAEs Per Infusion
120 ml/h
|
—
|
—
|
0.025 Number of local TEAEs/infusion
|
SECONDARY outcome
Timeframe: At the end of 4 weeks for each planned infusion parameterPopulation: SAS
Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response.
Outcome measures
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
n=12 Local TEAEs
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
n=31 Local TEAEs
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
n=28 Local TEAEs
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Time to Onset of Local TEAEs
25 ml
|
1.3 Days
Standard Deviation 2.45
|
—
|
—
|
|
Time to Onset of Local TEAEs
40 ml
|
0 Days
Standard Deviation 0.0
|
—
|
—
|
|
Time to Onset of Local TEAEs
25 ml/h
|
—
|
1.7 Days
Standard Deviation 2.94
|
—
|
|
Time to Onset of Local TEAEs
50 ml/h
|
—
|
0.0 Days
Standard Deviation 0.04
|
—
|
|
Time to Onset of Local TEAEs
75 ml/h
|
—
|
0 Days
Standard Deviation 0.0
|
—
|
|
Time to Onset of Local TEAEs
100 ml/h
|
—
|
0 Days
Standard Deviation NA
Not estimable because events = 1
|
—
|
|
Time to Onset of Local TEAEs
30 ml/h
|
—
|
—
|
0.2 Days
Standard Deviation 0.41
|
|
Time to Onset of Local TEAEs
60 ml/h
|
—
|
—
|
0.3 Days
Standard Deviation 0.59
|
|
Time to Onset of Local TEAEs
120 ml/h
|
—
|
—
|
0.2 Days
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: At the end of 4 weeks for each planned infusion parameterPopulation: SAS
Mild = A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate = A type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the subject. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.
Outcome measures
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
n=15 Participants
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
n=18 Participants
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
n=16 Participants
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Intensity of Local TEAEs
25 ml (mild)
|
3 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
25 ml (moderate)
|
0 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
25 ml (severe)
|
0 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
40 ml (mild)
|
1 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
40 ml (moderate)
|
0 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
40 ml (severe)
|
0 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
50 ml (mild)
|
0 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
50 ml (moderate)
|
0 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
50 ml (severe)
|
0 Participants
|
—
|
—
|
|
Intensity of Local TEAEs
25 ml/h (mild)
|
—
|
4 Participants
|
—
|
|
Intensity of Local TEAEs
25 ml/h (moderate)
|
—
|
2 Participants
|
—
|
|
Intensity of Local TEAEs
25 ml/h (severe)
|
—
|
0 Participants
|
—
|
|
Intensity of Local TEAEs
50 ml/h (mild)
|
—
|
3 Participants
|
—
|
|
Intensity of Local TEAEs
50 ml/h (moderate)
|
—
|
0 Participants
|
—
|
|
Intensity of Local TEAEs
50 ml/h (severe)
|
—
|
0 Participants
|
—
|
|
Intensity of Local TEAEs
75 ml/h (mild)
|
—
|
1 Participants
|
—
|
|
Intensity of Local TEAEs
75 ml/h (moderate)
|
—
|
0 Participants
|
—
|
|
Intensity of Local TEAEs
100 ml/h (moderate)
|
—
|
0 Participants
|
—
|
|
Intensity of Local TEAEs
75 ml/h (severe)
|
—
|
0 Participants
|
—
|
|
Intensity of Local TEAEs
100 ml/h (mild)
|
—
|
0 Participants
|
—
|
|
Intensity of Local TEAEs
100 ml/h (severe)
|
—
|
1 Participants
|
—
|
|
Intensity of Local TEAEs
30 ml/h (mild)
|
—
|
—
|
3 Participants
|
|
Intensity of Local TEAEs
30 ml/h (moderate)
|
—
|
—
|
0 Participants
|
|
Intensity of Local TEAEs
30 ml/h (severe)
|
—
|
—
|
0 Participants
|
|
Intensity of Local TEAEs
60 ml/h (mild)
|
—
|
—
|
4 Participants
|
|
Intensity of Local TEAEs
60 ml/h (moderate)
|
—
|
—
|
0 Participants
|
|
Intensity of Local TEAEs
60 ml/h (severe)
|
—
|
—
|
0 Participants
|
|
Intensity of Local TEAEs
120 ml/h (mild)
|
—
|
—
|
2 Participants
|
|
Intensity of Local TEAEs
120 ml/h (moderate)
|
—
|
—
|
0 Participants
|
|
Intensity of Local TEAEs
120 ml/h (severe)
|
—
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: At the end of 4 weeks for each planned infusion parameterPopulation: SAS
Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions".
Outcome measures
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
n=12 Local TEAEs
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
n=31 Local TEAEs
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
n=28 Local TEAEs
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Duration of Local TEAEs
25 ml
|
2.2 Days
Standard Deviation 1.30
|
—
|
—
|
|
Duration of Local TEAEs
40 ml
|
2.7 Days
Standard Deviation 2.08
|
—
|
—
|
|
Duration of Local TEAEs
25 ml/h
|
—
|
1.2 Days
Standard Deviation 0.37
|
—
|
|
Duration of Local TEAEs
50 ml/h
|
—
|
1.6 Days
Standard Deviation 0.92
|
—
|
|
Duration of Local TEAEs
75 ml/h
|
—
|
1.0 Days
Standard Deviation 0.00
|
—
|
|
Duration of Local TEAEs
100 ml/h
|
—
|
1.0 Days
Standard Deviation NA
Not estimable because events = 1
|
—
|
|
Duration of Local TEAEs
30 ml/h
|
—
|
—
|
2.2 Days
Standard Deviation 2.86
|
|
Duration of Local TEAEs
60 ml/h
|
—
|
—
|
5.6 Days
Standard Deviation 12.91
|
|
Duration of Local TEAEs
120 ml/h
|
—
|
—
|
3.0 Days
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: At the end of 4 weeks for each planned infusion parameterPopulation: SAS
Tolerability = number of infusions without severe local adverse events / total number of infusions. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.
Outcome measures
| Measure |
IgPro20 (Pump-Assisted Volume Cohort)
n=152 Infusions
Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Pump Assisted Flow Rate Cohort)
n=222 Infusions
Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
IgPro20 (Manual Push Flow Rate Cohort)
n=626 Infusions
Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.
IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
|
|---|---|---|---|
|
Tolerability of Infusions
25 ml
|
1.00 Ratio
|
—
|
—
|
|
Tolerability of Infusions
40 ml
|
1.00 Ratio
|
—
|
—
|
|
Tolerability of Infusions
50 ml
|
1.00 Ratio
|
—
|
—
|
|
Tolerability of Infusions
25 ml/h
|
—
|
1.00 Ratio
|
—
|
|
Tolerability of Infusions
50 ml/h
|
—
|
1.00 Ratio
|
—
|
|
Tolerability of Infusions
75 ml/h
|
—
|
1.00 Ratio
|
—
|
|
Tolerability of Infusions
100 ml/h
|
—
|
0.98 Ratio
|
—
|
|
Tolerability of Infusions
30 ml/h
|
—
|
—
|
1.00 Ratio
|
|
Tolerability of Infusions
60 ml/h
|
—
|
—
|
1.00 Ratio
|
|
Tolerability of Infusions
120 ml/h
|
—
|
—
|
1.00 Ratio
|
Adverse Events
IgPro20 (Pump-assisted Volume) 25 mL
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
IgPro20 (Pump-assisted Volume) 40 mL
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
IgPro20 (Pump-assisted Volume) 50 mL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
IgPro20 (Pump-assisted Flow Rate) 25 mL/h
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
IgPro20 (Pump-assisted Flow Rate) 50 mL/h
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
IgPro20 (Pump-assisted Flow Rate) 75 mL/h
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IgPro20 (Pump-assisted Flow Rate) 100 mL/h
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IgPro20 (Manual Push Flow Rate) 30 mL/h
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IgPro20 (Manual Push Flow Rate) 60 mL/h
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
IgPro20 (Manual Push Flow Rate) 120 mL/h
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IgPro20 (Pump-assisted Volume) 25 mL
n=15 participants at risk
Volumes per injection site of 25 mL administered subcutaneously.
|
IgPro20 (Pump-assisted Volume) 40 mL
n=12 participants at risk
Volumes per injection site of 40 mL administered subcutaneously.
|
IgPro20 (Pump-assisted Volume) 50 mL
n=11 participants at risk
Volumes per injection site of 50 mL administered subcutaneously.
|
IgPro20 (Pump-assisted Flow Rate) 25 mL/h
n=18 participants at risk
Flow rates per injection site of 25 mL/hour administered subcutaneously.
|
IgPro20 (Pump-assisted Flow Rate) 50 mL/h
n=14 participants at risk
Flow rates per injection site of 50 mL/hour administered subcutaneously.
|
IgPro20 (Pump-assisted Flow Rate) 75 mL/h
n=13 participants at risk
Flow rates per injection site of 75 mL/hour administered subcutaneously.
|
IgPro20 (Pump-assisted Flow Rate) 100 mL/h
n=12 participants at risk
Flow rates per injection site of 100 mL/hour administered subcutaneously.
|
IgPro20 (Manual Push Flow Rate) 30 mL/h
n=16 participants at risk
Flow rates per injection site of approximately 30 mL/hour administered subcutaneously.
|
IgPro20 (Manual Push Flow Rate) 60 mL/h
n=16 participants at risk
Flow rates per injection site of approximately 60 mL/hour administered subcutaneously.
|
IgPro20 (Manual Push Flow Rate) 120 mL/h
n=14 participants at risk
Flow rates per injection site of approximately 120 mL/hour administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
suicide attempt
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
Other adverse events
| Measure |
IgPro20 (Pump-assisted Volume) 25 mL
n=15 participants at risk
Volumes per injection site of 25 mL administered subcutaneously.
|
IgPro20 (Pump-assisted Volume) 40 mL
n=12 participants at risk
Volumes per injection site of 40 mL administered subcutaneously.
|
IgPro20 (Pump-assisted Volume) 50 mL
n=11 participants at risk
Volumes per injection site of 50 mL administered subcutaneously.
|
IgPro20 (Pump-assisted Flow Rate) 25 mL/h
n=18 participants at risk
Flow rates per injection site of 25 mL/hour administered subcutaneously.
|
IgPro20 (Pump-assisted Flow Rate) 50 mL/h
n=14 participants at risk
Flow rates per injection site of 50 mL/hour administered subcutaneously.
|
IgPro20 (Pump-assisted Flow Rate) 75 mL/h
n=13 participants at risk
Flow rates per injection site of 75 mL/hour administered subcutaneously.
|
IgPro20 (Pump-assisted Flow Rate) 100 mL/h
n=12 participants at risk
Flow rates per injection site of 100 mL/hour administered subcutaneously.
|
IgPro20 (Manual Push Flow Rate) 30 mL/h
n=16 participants at risk
Flow rates per injection site of approximately 30 mL/hour administered subcutaneously.
|
IgPro20 (Manual Push Flow Rate) 60 mL/h
n=16 participants at risk
Flow rates per injection site of approximately 60 mL/hour administered subcutaneously.
|
IgPro20 (Manual Push Flow Rate) 120 mL/h
n=14 participants at risk
Flow rates per injection site of approximately 120 mL/hour administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hot flush
|
0.00%
0/15 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Injection site swelling
|
6.7%
1/15 • Number of events 4 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
11.1%
2/18 • Number of events 3 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 3 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
General disorders
Injection site erythema
|
6.7%
1/15 • Number of events 1 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 2 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
16.7%
3/18 • Number of events 8 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 3 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Injection site pain
|
6.7%
1/15 • Number of events 2 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
11.1%
2/18 • Number of events 7 • Up to 17 weeks per participant
|
14.3%
2/14 • Number of events 5 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 4 • Up to 17 weeks per participant
|
12.5%
2/16 • Number of events 4 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
General disorders
Injection site extravasation
|
6.7%
1/15 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Injection site hemorrhage
|
6.7%
1/15 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
7.7%
1/13 • Number of events 2 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Injection site mass
|
0.00%
0/15 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Injection site pruritus
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
11.1%
2/18 • Number of events 2 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 2 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 2 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Injection site bruising
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 2 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 3 • Up to 17 weeks per participant
|
|
General disorders
Injection site discoloration
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 2 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Injection site reaction
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Gait inability
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
General disorders
Fatigue
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
7.7%
1/13 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
14.3%
2/14 • Number of events 2 • Up to 17 weeks per participant
|
7.7%
1/13 • Number of events 1 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
12.5%
2/16 • Number of events 3 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
12.5%
2/16 • Number of events 3 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/15 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
5.6%
1/18 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
7.7%
1/13 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
7.7%
1/13 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/15 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
5.6%
1/18 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
7.7%
1/13 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
9.1%
1/11 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Tinea infection
|
6.7%
1/15 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
8.3%
1/12 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
5.6%
1/18 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
14.3%
2/14 • Number of events 2 • Up to 17 weeks per participant
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
6.2%
1/16 • Number of events 1 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/15 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/11 • Up to 17 weeks per participant
|
0.00%
0/18 • Up to 17 weeks per participant
|
0.00%
0/14 • Up to 17 weeks per participant
|
0.00%
0/13 • Up to 17 weeks per participant
|
0.00%
0/12 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
0.00%
0/16 • Up to 17 weeks per participant
|
7.1%
1/14 • Number of events 1 • Up to 17 weeks per participant
|
Additional Information
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 requires 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