Trial Outcomes & Findings for Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome (NCT NCT02176863)
NCT ID: NCT02176863
Last Updated: 2025-12-05
Results Overview
The 2MWD was used to assess physical performance by measuring the distance that a participant can quickly walk at a self-preferred speed on an indoor flat, hard surface 30 m (100-ft) hallway in a period of 2 minutes. A positive change from baseline indicates improvement (i.e. a patient can walk farther). Increase in distance walked (in meters) indicates improvement.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
191 participants
Primary outcome timeframe
Baseline to Week 52
Results posted on
2025-12-05
Participant Flow
Participants took part in the study from 23 September 2014 to 24 November 2022.
A total of 238 participants were screened, out of which 191 participants were randomized in the study. Participants with post-polio syndrome (PPS) were randomized to receive Flebogamma® 5% DIF or placebo during Stage 1 or 2 of the study. During Stage 1, 161 participants were screened, of which 126 participants were randomized in the study. During Stage 2, 77 participants were screened, of which 65 participants were randomized in the study.
Participant milestones
| Measure |
Stage 1 Arm 3: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 2: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
42
|
33
|
32
|
|
Overall Study
COMPLETED
|
33
|
25
|
34
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
9
|
17
|
8
|
7
|
6
|
Reasons for withdrawal
| Measure |
Stage 1 Arm 3: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 2: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
10
|
4
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
2
|
3
|
4
|
|
Overall Study
Reason not specified
|
1
|
0
|
1
|
2
|
1
|
Baseline Characteristics
Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome
Baseline characteristics by cohort
| Measure |
Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF
n=42 Participants
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF
n=42 Participants
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 1 Arm 3: Placebo
n=42 Participants
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF
n=33 Participants
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 2: Placebo
n=32 Participants
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 6.24 • n=9 Participants
|
62.3 years
STANDARD_DEVIATION 6.88 • n=6 Participants
|
62.2 years
STANDARD_DEVIATION 7.22 • n=9 Participants
|
65.1 years
STANDARD_DEVIATION 7.00 • n=205 Participants
|
63.9 years
STANDARD_DEVIATION 6.26 • n=16 Participants
|
63.2 years
STANDARD_DEVIATION 6.76 • n=82 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
27 Participants
n=9 Participants
|
22 Participants
n=205 Participants
|
22 Participants
n=16 Participants
|
115 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
11 Participants
n=205 Participants
|
10 Participants
n=16 Participants
|
76 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
4 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
20 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=9 Participants
|
36 Participants
n=6 Participants
|
36 Participants
n=9 Participants
|
29 Participants
n=205 Participants
|
31 Participants
n=16 Participants
|
171 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
6 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=9 Participants
|
40 Participants
n=6 Participants
|
40 Participants
n=9 Participants
|
31 Participants
n=205 Participants
|
31 Participants
n=16 Participants
|
182 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: ITT population included all participants who were randomized.
The 2MWD was used to assess physical performance by measuring the distance that a participant can quickly walk at a self-preferred speed on an indoor flat, hard surface 30 m (100-ft) hallway in a period of 2 minutes. A positive change from baseline indicates improvement (i.e. a patient can walk farther). Increase in distance walked (in meters) indicates improvement.
Outcome measures
| Measure |
Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF
n=42 Participants
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF
n=42 Participants
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 1 Arm 3: Placebo
n=42 Participants
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF
n=33 Participants
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 2: Placebo
n=32 Participants
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Physical Performance Assessed by Two-Minute Walk Distance (2MWD) Test
Baseline
|
109.03 meters (m)
Standard Deviation 30.564
|
112.55 meters (m)
Standard Deviation 27.987
|
105.86 meters (m)
Standard Deviation 31.942
|
101.18 meters (m)
Standard Deviation 22.588
|
107.10 meters (m)
Standard Deviation 30.167
|
|
Change From Baseline in Physical Performance Assessed by Two-Minute Walk Distance (2MWD) Test
Change from Baseline at Week 52
|
7.50 meters (m)
Standard Deviation 14.666
|
10.89 meters (m)
Standard Deviation 19.067
|
3.17 meters (m)
Standard Deviation 11.080
|
11.31 meters (m)
Standard Deviation 12.108
|
5.65 meters (m)
Standard Deviation 10.388
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITT population included all participants who were randomized. As pre-specified in SAP, the analyses was performed over the two stages combined, using the placebo and selected dose of Flebogamma® 5% DIF treatment groups.
VAS is a participant self-reported pain scale used to evaluate the pain level in a 24 hours period. The scale consists of a 100 millimeters (mm) scale where 100 mm stands for the worst imaginable pain and zero stands for no pain. Higher scores indicate severe pain. A negative change from baseline indicates improvement. LS mean and 95% (CI) were based on MMRM method.
Outcome measures
| Measure |
Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF
n=75 Participants
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF
n=74 Participants
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 1 Arm 3: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 2: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Pain Using Visual Analogue Scale (VAS) of Pain
|
-3.2 millimeter (mm)
Interval -10.4 to 4.1
|
-2.6 millimeter (mm)
Interval -9.9 to 4.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITT population included all participants who were randomized. As pre-specified in SAP, the analyses was performed over the two stages combined, using the placebo and selected dose of Flebogamma® 5% DIF treatment groups.
HRQoL SF-36 is participant self-reported survey.It yields 8-scale profile of functional health and well-being as well as physical and mental health summary measures. It consists of the subscales:physical functioning,limitations due to physical health,body pain,general health,vitality,social functioning,emotional problems, and mental health. Each domain score ranges from 0(worst) to 100(best),higher scores reflect better functional status.PCS is a subscale score \& give broader metric of physical HRQoL.PCS score ranges from 0 to 100 and is computed such that mean score of 50 corresponds to the general US population.Based on norm-based scoring,scores above 50 is better-than-average health \& below 50 is below-average health.Higher scores represents better physical health.Positive change from baseline indicates improvement.LS mean and 95% CI were based on MMRM.
Outcome measures
| Measure |
Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF
n=75 Participants
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF
n=74 Participants
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 1 Arm 3: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 2: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Health-Related Quality of Life (HRQoL) Assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
|
4.78 Score on a scale
Interval 1.9 to 7.6
|
2.79 Score on a scale
Interval -0.1 to 5.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITT population included all participants who were randomized. As pre-specified in SAP, the analyses was performed over the two stages combined, using the placebo and selected dose of Flebogamma® 5% DIF treatment groups.
The 6MWD was used to assess physical performance by measuring the distance that a patient can quickly walk at maximal speed on a flat, hard surface 30 m (100-ft) hallway in a period of 6 minutes. A positive change from baseline indicates improvement (i.e., a patient can walk farther). Increase from baseline in distance walked (in meters) indicated improvement. LS mean and 95% CI were based on MMRM method.
Outcome measures
| Measure |
Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF
n=75 Participants
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF
n=74 Participants
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 1 Arm 3: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Stage 2 Arm 2: Placebo
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Endurance Assessed by Six-Minute Walk Distance (6MWD) Test
|
29.16 meters (m)
Interval 7.54 to 50.78
|
13.36 meters (m)
Interval -8.22 to 34.95
|
—
|
—
|
—
|
Adverse Events
Flebogamma® 5% DIF 2 g/kg
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Flebogamma® 5% DIF 1 g/kg
Serious events: 7 serious events
Other events: 71 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flebogamma® 5% DIF 2 g/kg
n=42 participants at risk
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Flebogamma® 5% DIF 1 g/kg
n=75 participants at risk
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1 followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days every 4 weeks for 52 weeks during Stage 1 and then every 4 weeks for 52 weeks during stage 2 of the study. The order of 1 g/kg of Flebogamma® 5% DIF was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Placebo
n=74 participants at risk
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks during Stage 1 and then every 4 weeks for 52 weeks during stage 2 of the study.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Social circumstances
Miscarriage of partner
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Investigations
Diagnostic procedure
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Nervous system disorders
Meningism
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Infections and infestations
Pyelonephritis
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
Other adverse events
| Measure |
Flebogamma® 5% DIF 2 g/kg
n=42 participants at risk
Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks.
|
Flebogamma® 5% DIF 1 g/kg
n=75 participants at risk
Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1 followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days every 4 weeks for 52 weeks during Stage 1 and then every 4 weeks for 52 weeks during stage 2 of the study. The order of 1 g/kg of Flebogamma® 5% DIF was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period.
|
Placebo
n=74 participants at risk
Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks during Stage 1 and then every 4 weeks for 52 weeks during stage 2 of the study.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
2/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.0%
3/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.4%
4/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
9.3%
7/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
10.8%
8/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Gastrointestinal disorders
Nausea
|
26.2%
11/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
17.3%
13/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.4%
4/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
6/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
6.7%
5/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.1%
3/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
General disorders
Chills
|
19.0%
8/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
20.0%
15/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
General disorders
Fatigue
|
33.3%
14/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
29.3%
22/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
27.0%
20/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
General disorders
Influenza like illness
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
13.3%
10/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.1%
3/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
General disorders
Infusion site swelling
|
4.8%
2/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.4%
4/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
General disorders
Non-cardiac chest pain
|
4.8%
2/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
General disorders
Oedema peripheral
|
4.8%
2/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.0%
3/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
10.8%
8/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
General disorders
Pain
|
7.1%
3/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
6.7%
5/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
General disorders
Pyrexia
|
19.0%
8/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
17.3%
13/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Infections and infestations
Cystitis
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.4%
4/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Infections and infestations
Influenza
|
9.5%
4/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
12.0%
9/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
4/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
10.7%
8/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
14.9%
11/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.0%
3/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.4%
4/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
2/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
6.7%
5/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
10.8%
8/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Investigations
Blood pressure increased
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
10.7%
8/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Investigations
Fibrin D dimer increased
|
7.1%
3/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
6.7%
5/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
6.8%
5/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.0%
8/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
16.0%
12/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
16.2%
12/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.9%
5/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
10.7%
8/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
8.1%
6/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.4%
4/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
6/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
13.3%
10/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.1%
3/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
3/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
13.3%
10/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
6.8%
5/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
17.6%
13/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Nervous system disorders
Headache
|
64.3%
27/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
52.0%
39/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
31.1%
23/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.1%
3/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Nervous system disorders
Migraine
|
4.8%
2/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
6.7%
5/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
6.7%
5/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.4%
4/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Product Issues
Device dislocation
|
7.1%
3/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
4/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.0%
3/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.5%
4/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.3%
1/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.1%
3/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
2.7%
2/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
2/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
5.3%
4/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
1.4%
1/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
2/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
9.3%
7/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.1%
3/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
14.7%
11/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Vascular disorders
Hypertension
|
16.7%
7/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
16.0%
12/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
10.8%
8/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
|
Vascular disorders
Phlebitis
|
7.1%
3/42 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
4.0%
3/75 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
0.00%
0/74 • From the start of study drug administration through 4 weeks after last study treatment (Up to Week 56)
The Safety population included all participants who received at least 1 infusion of investigational product (Flebogamma® 5% DIF or placebo). As pre-specified in the SAP, the combined safety data from both Stage 1 and Stage 2 together was summarized by treatment arm. Safety analyses was performed according to the actual treatment received. Only On Treatment Treatment-Emergent Adverse Events have been reported.
|
Additional Information
Sandra Camprubi, PhD/Senior Director, Clinical Operations
Instituto Grifols, S.A.
Phone: +34 67 0923160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor 30 days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At the Sponsors' request, the Site will remove any Confidential Information (other than Study results), and the Site will upon Sponsors' request, delay publication or presentation for a period of up to 120 days to allow the Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER