Trial Outcomes & Findings for A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency (NCT NCT00389324)
NCT ID: NCT00389324
Last Updated: 2015-04-20
Results Overview
Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
IV Phase (21 or 28 days) at IV Visit #1, pre- and post-dose: 0 hr., 1 hr., and 1, 2, 3, 5, 7, 14, 21, and 28 days; SC Phase at Week #17, pre- and post-dose: 0 hr., and 1, 3, 4, 5, and 7 days
Results posted on
2015-04-20
Participant Flow
First Patient, First Visit: Nov. 21, 2006, Last patient, Last visit: Aug. 26, 2008. This study was performed at medical clinics.
Participant milestones
| Measure |
IGIV-C
21 subjects were required to enter a Run-In Phase (3 to 4 months) and received IGIV-C between 200 and 600 mg/kg by intravenous infusion every 3 or 4 weeks. 18 subjects completed the Run-In Phase and entered the Intravenous Phase.
A total of 32 subjects entered the IV Phase: 14 subjects who had received IV IGIV-C prior to screening directly entered the IV Phase and 18 subjects who had completed the Run-in Phase continued in the study to enter the IV Phase. Subjects in the IV Phase received two IV infusions at the same dose (200-600 mg/kg) and frequency (every 3 or 4 weeks) as their regular dose at screening or during the Run-In Phase. All 32 subjects completed the IV Phase and entered the SC Phase.
A total of 32 subjects who completed the IV Phase entered the SC Phase. Subjects in the SC Phase received IGIV-C via weekly SC administration for 24 weeks total at a dose that was calculated using a conversion factor and their established IV dose. 25 subjects completed the SC Phase.
|
|---|---|
|
Run-In Phase
STARTED
|
21
|
|
Run-In Phase
COMPLETED
|
18
|
|
Run-In Phase
NOT COMPLETED
|
3
|
|
Intravenous Phase
STARTED
|
32
|
|
Intravenous Phase
COMPLETED
|
32
|
|
Intravenous Phase
NOT COMPLETED
|
0
|
|
Subcutaneous Phase
STARTED
|
32
|
|
Subcutaneous Phase
COMPLETED
|
25
|
|
Subcutaneous Phase
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
IGIV-C
21 subjects were required to enter a Run-In Phase (3 to 4 months) and received IGIV-C between 200 and 600 mg/kg by intravenous infusion every 3 or 4 weeks. 18 subjects completed the Run-In Phase and entered the Intravenous Phase.
A total of 32 subjects entered the IV Phase: 14 subjects who had received IV IGIV-C prior to screening directly entered the IV Phase and 18 subjects who had completed the Run-in Phase continued in the study to enter the IV Phase. Subjects in the IV Phase received two IV infusions at the same dose (200-600 mg/kg) and frequency (every 3 or 4 weeks) as their regular dose at screening or during the Run-In Phase. All 32 subjects completed the IV Phase and entered the SC Phase.
A total of 32 subjects who completed the IV Phase entered the SC Phase. Subjects in the SC Phase received IGIV-C via weekly SC administration for 24 weeks total at a dose that was calculated using a conversion factor and their established IV dose. 25 subjects completed the SC Phase.
|
|---|---|
|
Run-In Phase
Adverse Event
|
1
|
|
Run-In Phase
Lost to Follow-up
|
1
|
|
Run-In Phase
Withdrawal by Subject
|
1
|
|
Subcutaneous Phase
Adverse Event
|
2
|
|
Subcutaneous Phase
Non-compliance with study medication
|
2
|
|
Subcutaneous Phase
Withdrawal by Subject
|
2
|
|
Subcutaneous Phase
Lost to Follow-up
|
1
|
Baseline Characteristics
A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency
Baseline characteristics by cohort
| Measure |
Safety Population
n=35 Participants
The safety population included all subjects who received any amount of study medication (IGIV-C) via intravenous (IV) and/or subcutaneous (SC) routes of administration. As such, the safety population included all study participants combined (who received any dose), whether they entered the study in the Run-In or Intravenous Phase.
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: IV Phase (21 or 28 days) at IV Visit #1, pre- and post-dose: 0 hr., 1 hr., and 1, 2, 3, 5, 7, 14, 21, and 28 days; SC Phase at Week #17, pre- and post-dose: 0 hr., and 1, 3, 4, 5, and 7 daysPopulation: A total of 32 subjects in the IV phase and 26 subjects in the SC phase had sufficient plasma concentration of total IgG vs. time profiles (AUC) for assessment of steady-state PK parameters.
Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).
Outcome measures
| Measure |
Gamunex Intravenous (IV) Administration
n=32 Participants
Subjects who received Gamunex via IV administration.
|
Gamunex Subcutaneous (SC) Administration
n=26 Participants
Subjects who received Gamunex via SC administration.
|
|---|---|---|
|
Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)
|
7549 mg*hr/ml
Standard Deviation 1217 • Interval 0.861 to 0.917
|
6706 mg*hr/ml
Standard Deviation 1241 • Interval 0.861 to 0.917
|
Adverse Events
Run-In Phase
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Intravenous Phase
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Subcutaneous Phase
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-In Phase
n=21 participants at risk
All subjects who participated in the Run-In Phase.
|
Intravenous Phase
n=32 participants at risk
All subjects who participated in the Intravenous Phase.
|
Subcutaneous Phase
n=32 participants at risk
All subjects who participated in the Subcutaneous Phase.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Sepsis syndrome
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
4.8%
1/21 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
3.1%
1/32 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
Other adverse events
| Measure |
Run-In Phase
n=21 participants at risk
All subjects who participated in the Run-In Phase.
|
Intravenous Phase
n=32 participants at risk
All subjects who participated in the Intravenous Phase.
|
Subcutaneous Phase
n=32 participants at risk
All subjects who participated in the Subcutaneous Phase.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 3 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
15.6%
5/32 • Number of events 8 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
3.1%
1/32 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
12.5%
4/32 • Number of events 6 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
15.6%
5/32 • Number of events 6 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 3 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 5 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
9.4%
3/32 • Number of events 3 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Ear infection
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 3 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Sinusitis
|
9.5%
2/21 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
25.0%
8/32 • Number of events 11 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
21.9%
7/32 • Number of events 8 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Infections and infestations
Viral infection
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 3 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
9.4%
3/32 • Number of events 6 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 8 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
3.1%
1/32 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
18.8%
6/32 • Number of events 37 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Psychiatric disorders
Insomnia
|
9.5%
2/21 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
3.1%
1/32 • Number of events 1 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
9.4%
3/32 • Number of events 3 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 2 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site bruising
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
21.9%
7/32 • Number of events 13 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site erythema
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
40.6%
13/32 • Number of events 125 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
25.0%
8/32 • Number of events 13 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
15.6%
5/32 • Number of events 11 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site induration
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 5 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site oedema
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
12.5%
4/32 • Number of events 54 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site pain
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
40.6%
13/32 • Number of events 59 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site pruritus
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
25.0%
8/32 • Number of events 54 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site rash
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 5 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site swelling
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
34.4%
11/32 • Number of events 54 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
|
General disorders
Infusion site urticaria
|
0.00%
0/21 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
0.00%
0/32 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
6.2%
2/32 • Number of events 25 • Run-in phase (if required): 3 - 4 months; Intravenous Phase: 4 - 5 weeks; Subcutaneous Phase: 24 weeks.
Subjects were carefully monitored for adverse events. This monitoring includes clinical and laboratory tests and physical signs such as local reactions at subcutaneous infusion sites. Adverse events were assessed in terms of their seriousness, severity, and relationship to the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution or Principal investigator (PI) furnishes Talecris a copy of any proposed publication (either in writing or oral) of results of the study performed under the protocol, at least 30 days before the date of submission for publication or presentation. Talecris can ask the Principal Investigator to remove Confidential Information before publication or Talecris shall have an additional time, not to exceed 60 days, to file a patent application for such Confidential Information.
- Publication restrictions are in place
Restriction type: OTHER