Trial Outcomes & Findings for A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) (NCT NCT04346108)
NCT ID: NCT04346108
Last Updated: 2024-03-22
Results Overview
Total serum trough levels of IgG antibodies measured during period 2 of Epoch 2 were assessed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
17 participants
Primary outcome timeframe
Epoch 2 (period 2): Up to 24 weeks
Results posted on
2024-03-22
Participant Flow
Participants took part in the study at 8 investigative sites in Japan from 11 August 2020 to 22 December 2021.
Participants diagnosed with primary immunodeficiency diseases (PID) received immunoglobulin administered intravenously (IGIV) in Epoch 1, followed by immunoglobulin administered subcutaneously (IGSC) 20% in Epoch 2 and then followed by Epoch 3 respectively for up to approximately 50 weeks.
Participant milestones
| Measure |
Epoch 1: IGIV 200-600 mg/kg
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 3 or 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC (20%) 50-200 mg/kg
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 3: IGSC (20%) 100-400 mg/kg
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to approximately 12 weeks after Epoch 2.
|
|---|---|---|---|
|
Epoch 1 (13 Weeks)
STARTED
|
17
|
0
|
0
|
|
Epoch 1 (13 Weeks)
COMPLETED
|
17
|
0
|
0
|
|
Epoch 1 (13 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Epoch 2 (24 Weeks After Epoch 1)
STARTED
|
0
|
17
|
0
|
|
Epoch 2 (24 Weeks After Epoch 1)
COMPLETED
|
0
|
15
|
0
|
|
Epoch 2 (24 Weeks After Epoch 1)
NOT COMPLETED
|
0
|
2
|
0
|
|
Epoch 3 (12 Weeks After Epoch 2)
STARTED
|
0
|
0
|
7
|
|
Epoch 3 (12 Weeks After Epoch 2)
COMPLETED
|
0
|
0
|
7
|
|
Epoch 3 (12 Weeks After Epoch 2)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Epoch 1: IGIV 200-600 mg/kg
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 3 or 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC (20%) 50-200 mg/kg
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 3: IGSC (20%) 100-400 mg/kg
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to approximately 12 weeks after Epoch 2.
|
|---|---|---|---|
|
Epoch 2 (24 Weeks After Epoch 1)
Withdrawal by Parent/Guardian
|
0
|
1
|
0
|
|
Epoch 2 (24 Weeks After Epoch 1)
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)
Baseline characteristics by cohort
| Measure |
IGIV 200 to 600 mg/kg + IGSC [50 to 200 and 100 to 400] mg/kg
n=17 Participants
Participants received 200 to 600 mg/kg of IGIV infusion for every 3 or 4 weeks up to 13 weeks in Epoch 1; followed by approximately 50 to 200 mg/kg of IGSC infusion,20% once a week for a total of 24 weeks after Epoch 1 in Epoch 2; followed by approximately 100 to 400 mg/kg of IGSC infusion, 20% once every two weeks for a total of 12 weeks after Epoch 2 in Epoch 3.
|
|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 21.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight
|
48.16 kilogram (kg)
STANDARD_DEVIATION 18.120 • n=5 Participants
|
|
Height
|
152.15 centimeter (cm)
STANDARD_DEVIATION 20.076 • n=5 Participants
|
|
Body Mass Index (BMI)
|
19.88 kg/m^2
STANDARD_DEVIATION 3.242 • n=5 Participants
|
PRIMARY outcome
Timeframe: Epoch 2 (period 2): Up to 24 weeksPopulation: Pharmacokinetic Analysis Set (PKAS) 1 included all participants in the all-treated set who have had at least 1 evaluable serum IgG concentration value and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Only PKAS 1 participants in Epoch 2 were analyzed for this outcome measure.
Total serum trough levels of IgG antibodies measured during period 2 of Epoch 2 were assessed.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Total Serum Trough Levels of Immune Globulin G (IgG) Antibodies During Period 2
|
8.56 grams per liter (g/L)
Interval 8.03 to 9.12
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Epoch 3: Up to Week 12Population: PKAS 1 included all participants in the all-treated set who have had at least 1 evaluable serum IgG concentration value and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Only PKAS 1 participants in Epoch 3 were analyzed for this outcome measure.
Total serum trough levels of IgG antibodies measured during Epoch 3 were assessed.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 3: Total Serum Trough Levels of IgG Antibodies
|
8.39 g/L
Interval 7.89 to 8.91
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 1: Up to Week 13Population: PKAS 1 included all participants in the all-treated set who have had at least 1 evaluable serum IgG concentration value and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Only PKAS 1 participants in Epoch 1 were analyzed for this outcome measure.
Total serum trough levels of IgG antibodies measured during Epoch 1 were assessed.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 1: Total Serum Trough Levels of IgG Antibodies
|
8.18 g/L
Interval 7.71 to 8.68
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Area Under the Curve From Time 0 to Last Interval (AUC0-last) for Total Serum Levels of IgG
|
58.9 g*day/L
Interval 48.7 to 71.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Total serum levels of IgG subclasses IgG 1, IgG 2, IgG 3, and IgG 4 were determined.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: AUC0-last for Total Serum Levels of IgG Subclasses
IgG 1
|
35.8 g*day/L
Interval 32.4 to 39.5
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: AUC0-last for Total Serum Levels of IgG Subclasses
IgG 2
|
23.4 g*day/L
Interval 20.4 to 26.9
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: AUC0-last for Total Serum Levels of IgG Subclasses
IgG 3
|
1.32 g*day/L
Interval 0.624 to 2.8
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: AUC0-last for Total Serum Levels of IgG Subclasses
IgG 4
|
1.67 g*day/L
Interval 1.1 to 2.53
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Apparent Clearance (CL/F) for Total Serum Levels of IgG
|
1.93 mL/kg/day
Interval 1.71 to 2.19
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Total serum levels of IgG subclasses IgG 1, IgG 2, IgG 3, and IgG 4 were determined.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: CL/F for Total Serum Levels of IgG Subclasses
IgG 1
|
3.18 mL/kg/day
Interval 2.88 to 3.51
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: CL/F for Total Serum Levels of IgG Subclasses
IgG 2
|
4.86 mL/kg/day
Interval 4.18 to 5.66
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: CL/F for Total Serum Levels of IgG Subclasses
IgG 3
|
99.5 mL/kg/day
Interval 37.1 to 266.0
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: CL/F for Total Serum Levels of IgG Subclasses
IgG 4
|
68.3 mL/kg/day
Interval 48.3 to 96.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Maximum Concentration (Cmax) for Total Serum Levels of IgG
|
9.08 g/L
Interval 7.46 to 11.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Total serum levels of IgG subclasses IgG 1, IgG 2, IgG 3, and IgG 4 were determined.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Cmax for Total Serum Levels of IgG Subclasses
IgG 1
|
5.40 g/L
Interval 4.95 to 5.89
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Cmax for Total Serum Levels of IgG Subclasses
IgG 2
|
3.51 g/L
Interval 3.06 to 4.03
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Cmax for Total Serum Levels of IgG Subclasses
IgG 3
|
0.202 g/L
Interval 0.096 to 0.425
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Cmax for Total Serum Levels of IgG Subclasses
IgG 4
|
0.256 g/L
Interval 0.169 to 0.387
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Minimum Concentration (Cmin) for Total Serum Levels of IgG
|
7.45 g/L
Interval 6.17 to 8.99
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Total serum levels of IgG subclasses IgG 1, IgG 2, IgG 3, and IgG 4 were determined.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Cmin for Total Serum Levels of IgG Subclasses
IgG 1
|
4.89 g/L
Interval 4.34 to 5.51
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Cmin for Total Serum Levels of IgG Subclasses
IgG 2
|
3.15 g/L
Interval 2.7 to 3.68
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Cmin for Total Serum Levels of IgG Subclasses
IgG 3
|
0.181 g/L
Interval 0.0861 to 0.381
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Cmin for Total Serum Levels of IgG Subclasses
IgG 4
|
0.218 g/L
Interval 0.153 to 0.311
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Time to Maximum Concentration (Tmax) for Total Serum Levels of IgG
|
71.08 hours
Interval 22.82 to 168.23
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 2: Week 21Population: PKAS 2 included all participants \>=12 years of age in the all-treated set who have had at least 1 evaluable serum IgG concentration value during Epoch 2 and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants with data available for analyses.
Total serum levels of IgG subclasses IgG 1, IgG 2, IgG 3, and IgG 4 were determined.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Epoch 2: Tmax for Total Serum Levels of IgG Subclasses
IgG 1
|
71.08 hours
Interval 22.82 to 118.8
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Tmax for Total Serum Levels of IgG Subclasses
IgG 2
|
71.08 hours
Interval 0.0 to 164.32
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Tmax for Total Serum Levels of IgG Subclasses
IgG 3
|
72.92 hours
Interval 71.08 to 118.8
|
—
|
—
|
—
|
—
|
—
|
|
Epoch 2: Tmax for Total Serum Levels of IgG Subclasses
IgG 4
|
71.17 hours
Interval 70.13 to 118.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Epoch 1 (Week 1); Epoch 2 (Week 1, 24); Epoch 3 (Week 1, 13)Population: PKAS 1 included all participants in the all-treated set who have had at least 1 evaluable serum IgG concentration value and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants available for analyses. Data is represented as per doses received for specific interval in each Epoch for this outcome measure.
Trough levels of specific antibodies to clinically relevant pathogen (Clostridium tetani toxoid and HBV) were assessed in Epoch 1, Epoch 2 and Epoch 3. Data was analyzed per interval in each Epoch for this outcome measure.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=5 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=12 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
n=10 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
n=7 Participants
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
n=7 Participants
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Trough Levels of Specific Antibodies to Clinically Relevant Pathogens: Clostridium Tetani Toxoid and Hepatitis B Virus (HBV)
Clostridium Tetani Toxoid
|
0.524 International units (IU)/mL
Interval 0.29 to 0.949
|
0.602 International units (IU)/mL
Interval 0.364 to 0.997
|
0.674 International units (IU)/mL
Interval 0.468 to 0.97
|
1.52 International units (IU)/mL
Interval 1.11 to 2.08
|
1.97 International units (IU)/mL
Interval 1.65 to 2.35
|
1.80 International units (IU)/mL
Interval 1.35 to 2.39
|
|
Trough Levels of Specific Antibodies to Clinically Relevant Pathogens: Clostridium Tetani Toxoid and Hepatitis B Virus (HBV)
Hepatitis B Virus
|
27.7 International units (IU)/mL
Interval 17.8 to 43.0
|
35.2 International units (IU)/mL
Interval 17.5 to 70.9
|
54.1 International units (IU)/mL
Interval 33.7 to 87.0
|
486 International units (IU)/mL
Interval 335.0 to 706.0
|
645 International units (IU)/mL
Interval 452.0 to 920.0
|
923 International units (IU)/mL
Interval 832.0 to 1020.0
|
SECONDARY outcome
Timeframe: Epoch 1 (Week 1); Epoch 2 (Week 1, 24); Epoch 3 (Week 1, 13)Population: PKAS 1 included all participants in the all-treated set who have had at least 1 evaluable serum IgG concentration value and have had no major protocol deviations or events that would affect the serum IgG concentration analysis results. Overall number analyzed are the number of participants available for analyses. Data is represented as per doses received for specific intervals in each Epoch for this outcome measure.
Trough levels of specific antibodies to clinically relevant pathogens (HIB) were assessed in Epoch 1, Epoch 2, and Epoch 3. Data was analyzed per interval in each Epoch for this outcome measure.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=5 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=12 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
n=10 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
n=7 Participants
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
n=7 Participants
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Trough Levels of Specific Antibodies to Clinically Relevant Pathogen: Haemophilus Influenzae (HIB)
|
1.58 mg/L
Interval 0.568 to 4.38
|
1.55 mg/L
Interval 1.11 to 2.18
|
2.50 mg/L
Interval 1.95 to 3.2
|
1.77 mg/L
Interval 1.07 to 2.91
|
2.04 mg/L
Interval 1.74 to 2.39
|
1.73 mg/L
Interval 1.46 to 2.04
|
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: All-Treated Set included all enrolled participants of age '2-13 years' and '\>=14 years' who received at least 1 dose of study drug (IGIV or IGSC). Number analyzed is the number of participants with data available for analyses at specific timepoints.
Treatment preference questionnaire is a self-administered questionnaire developed to assess participants' preference towards the administration of new IGSC therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the IGSC treatment. The questionnaire included following categories: Where do you prefer to receive your immunoglobulin therapy, The frequency of administration, as pre-specified in protocol, data is reported as per age (2-13 years and \>=14 years).
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=4 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=6 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=2 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
n=5 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Health Related Quality of Life: Treatment Preference
The Frequency of Administration: Like
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Health Related Quality of Life: Treatment Preference
Where do you Prefer to Receive Your Immunoglobulin Therapy: At Hospital
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Health Related Quality of Life: Treatment Preference
The Frequency of Administration: No Preference
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Health Related Quality of Life: Treatment Preference
The Frequency of Administration: Dislike Very Much
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Health Related Quality of Life: Treatment Preference
Where do you Prefer to Receive Your Immunoglobulin Therapy: At Home
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Health Related Quality of Life: Treatment Preference
Where do you Prefer to Receive Your Immunoglobulin Therapy: No Preference
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Health Related Quality of Life: Treatment Preference
The Frequency of Administration: Like Very Much
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
TEAEs was defined as adverse events (AEs) with onset after date-time of first dose of study drug, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. Any TEAE that is recorded by the investigator as "possibly related" or "probably related" to IP was considered as IGSC, 20%-related AE, and any AE recorded as "unlikely related" or "not related" was considered as unrelated AE. AEs included vital signs, clinical laboratory measurements.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
11 Participants
|
16 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
An infusion is considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to TEAE related to study drug (IGIV or IGSC) infusion. A tolerability event is considered to have occurred if an infusion was not tolerable in Epoch 1, Epoch 2 and Epoch 3. Number of participants with tolerability events related to infusion of IP were assessed.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Tolerability Events Related to the Infusion of Study Drug
Infusions With Infusion Rate Reduced or Interrupted or Stopped
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Tolerability Events Related to the Infusion of Study Drug
Infusions With Infusion Rate Reduced
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Tolerability Events Related to the Infusion of Study Drug
Infusions That Were Interrupted
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Tolerability Events Related to the Infusion of Study Drug
Infusions That Were Stopped
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
The ASBI rate was calculated as the mean number of acute serious bacterial infections per participants per year. Annual rate of validated acute serious bacterial infections per participant was assessed.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Annual Rate of Validated Acute Serious Bacterial Infections (ASBI)
|
0.0 number of infections per year
Standard Deviation 0.00
|
0.25 number of infections per year
Standard Deviation 1.042
|
0.0 number of infections per year
Standard Deviation 0.00
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
Annual rate is the number of participants reporting any infection per year.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Annual Rate of All Infections Per Year
|
1.65 number of infections per year
Standard Deviation 2.479
|
2.78 number of infections per year
Standard Deviation 3.074
|
0.00 number of infections per year
Standard Deviation 0.000
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
Number of days not able to attend school or work to perform normal daily activities due to illness/infection are standardized per year (365.25 days). The number of days not able to attend school or work to perform normal daily activities due to illness/infection were assessed.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Number of Days Participants Not Able to Attend School or Work to Perform Normal Daily Activities Due to Illness/Infection
|
0.00 days
Interval 0.0 to 16.1
|
0.00 days
Interval 0.0 to 17.2
|
4.30 days
Interval 0.0 to 38.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
Number of days on antibiotics is defined as the number of days those antibiotics were taken as concomitant medications and is standardized to per year (365.25 days). Antibiotics are defined as any medication under anatomical therapeutic chemical Level 2 therapeutic class "ANTIBACTERIALS FOR SYSTEMIC USE". If a participant took multiple antibiotics on a single day, that day is counted for only once. Protocol defined prophylactic antibiotics for viral, fungal or protozoal infections (e.g. trimethoprim/sulfamethoxazole twice a week for pneumocystis) which are not treated by immunoglobulin, were excluded from this analysis.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Number of Days Participants Were on Antibiotics
|
0.00 days
Interval 0.0 to 31.8
|
0.00 days
Interval 0.0 to 34.5
|
0.00 days
Interval 0.0 to 21.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
Number of participants with hospitalization are standardized to per year (365.25 days). A hospitalization is counted for a specific epoch only if that hospitalization started during that epoch.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Number of Participants Hospitalized Due to Illness or Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
Length of hospital stay per stay is standardized to per year (365.25 days). A hospitalization is counted for a specific epoch only if that hospitalization started during that epoch.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Length of Hospital Stay
|
0.00 days
Interval 0.0 to 0.0
|
0.00 days
Interval 0.0 to 17.4
|
0.00 days
Interval 0.0 to 0.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of study (up to approximately 1.5 years)Population: All-Treated Set included all enrolled participants who received at least 1 dose of study drug (IGIV or IGSC).
Number of acute physician visits is standardized to per year (365.25 days).
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=17 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
n=7 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Number of Acute Physician Visits Due to Illness/Infection
|
1.18 number of visits per year
Standard Deviation 3.098
|
3.30 number of visits per year
Standard Deviation 6.807
|
1.624 number of visits per year
Standard Deviation 8.121
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 1.5 years)Population: All-Treated Set included all enrolled participants of age group '2-7 years' and '8-13 years' who received at least 1 dose of study drug (IGIV or IGSC). Number analyzed are the number of participants with data available for analysis at the given timepoint.
Peds-QL=generic HR QoL instrument designed specifically for pediatrics has domains as:general health/activities,feelings/emotional,social functioning,school functioning.In this study,2-7 years (parent as observer),8-13 years (participant as observer) for Peds-QL health questionnaire was analyzed.Higher scores=better QOL for all domains.This modular instrument used 5-point scale:0(never) to 4(almost always).Items are reversed scored;linearly transformed to 0-100 scale as follows:0=100,1=75,2=50,3=25,4=0.4 dimensions(physical, emotional, social, \& school functioning) are scored.PEDS-QL Total Scale Score has 0-100 scale,higher scores=better HRQoL.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=2 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=4 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Health-related Quality of Life (HRQoL): Pediatric Quality of Life Inventory (PedsQL) Total Scale Score
IGIV: Epoch 1: Baseline (Week 1)
|
88.04 score on a scale
Standard Deviation 13.835
|
87.23 score on a scale
Standard Deviation 11.820
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Pediatric Quality of Life Inventory (PedsQL) Total Scale Score
IGSC: Epoch 3: Change from Baseline (EOS/ET])
|
3.26 score on a scale
Standard Deviation 7.686
|
4.08 score on a scale
Standard Deviation 16.374
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Pediatric Quality of Life Inventory (PedsQL) Total Scale Score
IGSC: Epoch 2: Change from Baseline (Week 1)
|
9.78 score on a scale
Standard Deviation 15.372
|
-6.79 score on a scale
Standard Deviation 9.977
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Pediatric Quality of Life Inventory (PedsQL) Total Scale Score
IGSC: Epoch 3: Change from Baseline (Week 1)
|
14.13 score on a scale
Standard Deviation NA
Standard deviation was not estimable for 1 participant
|
20.65 score on a scale
Standard Deviation NA
Standard deviation was not estimable due to 1 participant.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of the study (approximately 1.5 years)Population: All-Treated Set included all enrolled participants of age group '2-11 years' and '\>=12 years' who received at least 1 dose of study drug (IGIV or IGSC). Number analyzed is the number of participants with data available for analyses at specific timepoints
EQ-5D-3L health questionnaire=participant answered questionnaire scoring 5 dimensions -mobility,self-care,usual activities, pain/discomfort and anxiety/depression. n this study, 2-11 years (parent as observer),12 years and older (participant as observer) for EQ-5D-3L health questionnaire was analyzed.Health state index score range from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.EQ visual analogue scale range from 0 to 100, where higher scores indicate better health status.Data is reported as per age groups (2-11 years and \>=12 years).
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=4 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=13 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Total Scale Score
IGSC: Epoch 2: Change from Baseline (Week 1): EQ Visual Analogue Scale
|
-5.0 score on a scale
Standard Deviation 5.00
|
4.2 score on a scale
Standard Deviation 17.15
|
—
|
—
|
—
|
—
|
|
EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Total Scale Score
IGSC:Epoch 3: Change from Baseline (Week 1): EQ Visual Analogue Scale
|
0.0 score on a scale
Standard Deviation NA
Standard deviation was not estimable for 1 participant
|
-1.3 score on a scale
Standard Deviation 12.39
|
—
|
—
|
—
|
—
|
|
EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Total Scale Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Health State Index Score
|
0.0400 score on a scale
Standard Deviation 0.04619
|
0.0229 score on a scale
Standard Deviation 0.04566
|
—
|
—
|
—
|
—
|
|
EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Total Scale Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): EQ Visual Analogue Scale
|
1.3 score on a scale
Standard Deviation 6.29
|
6.9 score on a scale
Standard Deviation 13.21
|
—
|
—
|
—
|
—
|
|
EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Total Scale Score
IGSC: Epoch 2: Change from Baseline (Week 1): Health State Index Score
|
-0.0270 score on a scale
Standard Deviation 0.12275
|
0.0016 score on a scale
Standard Deviation 0.03318
|
—
|
—
|
—
|
—
|
|
EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Total Scale Score
IGSC: Epoch 3: Change from Baseline (Week 1): Health State Index Score
|
0.0000 score on a scale
Standard Deviation NA
Standard deviation was not estimable for 1 participant
|
0.0133 score on a scale
Standard Deviation 0.03266
|
—
|
—
|
—
|
—
|
|
EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Total Scale Score
IGIV: Epoch 1: Baseline (Week 1): Health State Index Score
|
0.8080 score on a scale
Standard Deviation 0.04619
|
0.8217 score on a scale
Standard Deviation 0.04544
|
—
|
—
|
—
|
—
|
|
EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Total Scale Score
IGIV: Epoch 1: Baseline (Week 1): EQ Visual Analogue Scale
|
87.5 score on a scale
Standard Deviation 15.55
|
77.1 score on a scale
Standard Deviation 22.16
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of the study (approximately 1.5 years)Population: All-Treated Set included all enrolled participants of age '14 years and above' who received at least 1 dose of study drug (IGIV or IGSC). Number analyzed is the number of participants with data available for analyses at specific timepoints.
SF-36=generic quality-of-life instrument that has been widely used to assess HRQL of participants.In this study, 14 years and older (participant as observer) for SF-36 health questionnaire was analyzed. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases.SF-36=36 items aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100.Higher scores=better HRQL. As pre-specified in protocol data is reported for participants with age group of 14 years or older.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=11 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Health-related Quality of Life (HRQoL): Short Form-36 Health Survey (SF-36) Score
IGIV: Epoch 1: Baseline (Week 1): Physical Component Summary Score
|
50.21 score on a scale
Standard Deviation 7.282
|
—
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Short Form-36 Health Survey (SF-36) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Physical Component Summary Score
|
0.10 score on a scale
Standard Deviation 7.142
|
—
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Short Form-36 Health Survey (SF-36) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Mental Component Summary Score
|
-0.30 score on a scale
Standard Deviation 2.294
|
—
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Short Form-36 Health Survey (SF-36) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Physical Component Summary Score
|
1.81 score on a scale
Standard Deviation 8.189
|
—
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Short Form-36 Health Survey (SF-36) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Physical Component Summary Score
|
0.23 score on a scale
Standard Deviation 4.649
|
—
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Short Form-36 Health Survey (SF-36) Score
IGIV: Epoch 1: Baseline (Week 1): Mental Component Summary Score
|
50.59 score on a scale
Standard Deviation 8.114
|
—
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Short Form-36 Health Survey (SF-36) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Mental Component Summary Score
|
3.60 score on a scale
Standard Deviation 5.352
|
—
|
—
|
—
|
—
|
—
|
|
Health-related Quality of Life (HRQoL): Short Form-36 Health Survey (SF-36) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Mental Component Summary Score
|
4.32 score on a scale
Standard Deviation 8.185
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of the study (approximately 1.5 years)Population: All-Treated Set included all enrolled participants of age group ' 2-12 years' and '\>=3 years' who received at least 1 dose of study drug (IGIV or IGSC). Number analyzed is the number of participants with data available for analyses at specific timepoints.
TSQM=is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. In this study, 2-12 years (parent as observer), 13 years and older (participant as observer) for TSQM health questionnaire will be analyzed. TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain. As pre-specified in protocol, data is reported as per age group (2-12 years and \>=13 years).
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=6 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=11 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGIV: Epoch 1: Baseline (Week 1): Effectiveness
|
69.44 score on a scale
Standard Deviation 14.380
|
75.25 score on a scale
Standard Deviation 18.817
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGIV: Epoch 1: Baseline (Week 1): Convenience
|
62.96 score on a scale
Standard Deviation 13.907
|
65.66 score on a scale
Standard Deviation 23.016
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Effectiveness
|
2.22 score on a scale
Standard Deviation 9.296
|
-1.52 score on a scale
Standard Deviation 10.568
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Convenience
|
3.33 score on a scale
Standard Deviation 16.942
|
5.05 score on a scale
Standard Deviation 13.484
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Convenience
|
13.89 score on a scale
Standard Deviation 19.642
|
15.56 score on a scale
Standard Deviation 12.669
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Global Satisfaction
|
-7.14 score on a scale
Standard Deviation 10.02
|
4.29 score on a scale
Standard Deviation 29.709
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Effectiveness
|
9.26 score on a scale
Standard Deviation 10.924
|
6.57 score on a scale
Standard Deviation 18.892
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Convenience
|
5.56 score on a scale
Standard Deviation 22.222
|
9.09 score on a scale
Standard Deviation 23.210
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Global Satisfaction
|
7.14 score on a scale
Standard Deviation 23.905
|
3.90 score on a scale
Standard Deviation 23.768
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGIV: Epoch 1: Baseline (Week 1): Global Satisfaction
|
75.00 score on a scale
Standard Deviation 17.928
|
74.68 score on a scale
Standard Deviation 18.173
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Global Satisfaction
|
-2.86 score on a scale
Standard Deviation 10.833
|
1.30 score on a scale
Standard Deviation 10.507
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Effectiveness
|
2.78 score on a scale
Standard Deviation 3.928
|
-10.00 score on a scale
Standard Deviation 52.673
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of the study (approximately 1.5 years)Population: All-Treated Set included all enrolled participants of age group '2-13 years' and '\>=14 years' who received at least 1 dose of study drug (IGIV or IGSC). Number analyzed is the number of participants with data available for analyses at specific timepoints.
LQI=self-administered questionnaire developed specifically for participants/legal guardians involved in IGIV treatments.2-13 years (parent as observer),14 years and older (participant as observer) for LQI health questionnaire was analyzed.LQI=15-items, divided into 4 domains: treatment interferences(TI)\[6 items\],therapy-related problems(TRP)\[4 items\],therapy setting(TS)\[3 items\];treatment costs(TC)\[2 items\].Items are rated on a 7-point Likert-type scale ranging from 1:"Extremely bad" to 7:"Extremely good".Total scores=0 to 100,higher scores=highest possible satisfaction with factors such as independence,therapy convenience,social/school/work activities;health and travel costs.As pre-specified in protocol, data is reported as per age (2-13 years and \>=14 years).All-Treated Set included all enrolled participants of age group '2-13 years' and '\>=14 years' who received at least 1 dose of study drug (IGIV or IGSC).'n'=Number analysed are participants with data available for analysis.
Outcome measures
| Measure |
Epoch 2: IGSC (20%) 50-200 mg/kg
n=6 Participants
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 1: IGIV 4-week Interval (Week 1)
n=11 Participants
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC, 20% Weekly (Week 1)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 2: IGSC, 20% Weekly (EOS [Week 24]/ET)
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to end of study (EOS) (24 weeks) or early termination (ET) after Epoch 1.
|
Epoch 3: IGSC, 20% Biweekly (Week 1)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
Epoch 3: IGSC, 20% Biweekly (Week 13)
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to EOS (13 weeks) after Epoch 2.
|
|---|---|---|---|---|---|---|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Factor 1 Treatment Interference
|
-2.78 score on a scale
Standard Deviation 13.494
|
-0.25 score on a scale
Standard Deviation 13.046
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Factor 2 Therapy-Related Problems
|
-1.39 score on a scale
Standard Deviation 9.001
|
1.14 score on a scale
Standard Deviation 9.334
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGIV: Epoch 1: Baseline (Week 1): Factor 1 Treatment Interference
|
81.48 score on a scale
Standard Deviation 14.873
|
77.02 score on a scale
Standard Deviation 17.963
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGIV: Epoch 1: Baseline (Week 1): Factor 2 Therapy-Related Problems
|
81.94 score on a scale
Standard Deviation 15.516
|
79.17 score on a scale
Standard Deviation 15.811
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGIV: Epoch 1: Baseline (Week 1): Factor 4 Treatment Costs
|
65.28 score on a scale
Standard Deviation 24.391
|
53.79 score on a scale
Standard Deviation 21.847
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Factor 1 Treatment Interference
|
4.17 score on a scale
Standard Deviation 1.964
|
3.33 score on a scale
Standard Deviation 4.120
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Factor 3 Therapy Setting
|
2.78 score on a scale
Standard Deviation 16.005
|
4.55 score on a scale
Standard Deviation 16.067
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 3: Change from Baseline (EOS/ET): Factor 4 Treatment Costs
|
4.17 score on a scale
Standard Deviation 16.672
|
14.39 score on a scale
Standard Deviation 26.898
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGIV: Epoch 1: Baseline (Week 1): Factor 3 Therapy Setting
|
77.78 score on a scale
Standard Deviation 20.488
|
74.75 score on a scale
Standard Deviation 23.748
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Factor 1 Treatment Interference
|
-8.33 score on a scale
Standard Deviation 21.445
|
-2.53 score on a scale
Standard Deviation 14.351
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Factor 2 Therapy-Related Problems
|
2.78 score on a scale
Standard Deviation 9.742
|
-1.52 score on a scale
Standard Deviation 15.841
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Factor 3 Therapy Setting
|
-6.48 score on a scale
Standard Deviation 30.106
|
0.51 score on a scale
Standard Deviation 11.773
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 2: Change from Baseline (Week 1): Factor 4 Treatment Costs
|
-9.72 score on a scale
Standard Deviation 22.618
|
0.76 score on a scale
Standard Deviation 31.282
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Factor 2 Therapy-Related Problems
|
-14.58 score on a scale
Standard Deviation 14.731
|
1.67 score on a scale
Standard Deviation 14.613
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Factor 3 Therapy Setting
|
19.44 score on a scale
Standard Deviation 3.928
|
12.22 score on a scale
Standard Deviation 16.387
|
—
|
—
|
—
|
—
|
|
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Life Quality Index (LQI) Score
IGSC: Epoch 3: Change from Baseline (Week 1): Factor 4 Treatment Costs
|
0.00 score on a scale
Standard Deviation 0.000
|
18.33 score on a scale
Standard Deviation 40.139
|
—
|
—
|
—
|
—
|
Adverse Events
Epoch 1: IGIV 200-600 mg/kg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Epoch 2: IGSC (20%) 50-200 mg/kg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Epoch 3: IGSC (20%) 100-400 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epoch 1: IGIV 200-600 mg/kg
n=17 participants at risk
Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 3 or 4 weeks for up to 13 weeks.
|
Epoch 2: IGSC (20%) 50-200 mg/kg
n=17 participants at risk
Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1.
|
Epoch 3: IGSC (20%) 100-400 mg/kg
n=7 participants at risk
Participants who entered to Epoch 3 from Epoch 2 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to approximately 12 weeks after Epoch 2.
|
|---|---|---|---|
|
Eye disorders
Myopia
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
17.6%
3/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site swelling
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
17.6%
3/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site erythema
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
17.6%
3/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.8%
2/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vaccination site pain
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.8%
2/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Administration site discolouration
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Administration site pain
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Administration site swelling
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site bruising
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site erythema
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site pain
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site pruritus
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site swelling
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site bruising
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site reaction
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Puncture site pain
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vaccination site joint erythema
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
2/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Conjunctivitis
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.8%
2/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.8%
2/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.8%
2/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Impetigo
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Parotitis
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Periodontitis
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic arthropathy
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Occult blood positive
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.8%
2/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
17.6%
3/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
17.6%
3/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Orthostatic intolerance
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From first dose of study drug up to end of study (up to approximately 1.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER