Trial Outcomes & Findings for CM-101 in PSC Patients -The SPRING Study (NCT NCT04595825)
NCT ID: NCT04595825
Last Updated: 2026-07-02
Results Overview
Number of subjects with treatment-emergent adverse events (any, related, serious, and severe) - Safety-related endpoint
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
15 week double-blind (DB) treatment period
Results posted on
2026-07-02
Participant Flow
The study was planned to be performed at approximately 75 sites globally. The study was conducted at 52 sites in Israel (first site open: Sept 2020), United Kingdom (first site open: Sept 2020), Spain (first site open: May 2022), Germany (first site open: Mar 2022), and the United States (first site open: Jun 2022).
A total of 134 patients were screened in the study across 52 sites globally. Of these, 57 patients failed to meet inclusion and/or exclusion criteria at screening. Inclusion/Exclusion criteria that excluded \>15% included 1. Serum ALP greater than 1.5 x ULN (31.0%) and 2. Subjects with evidence of cirrhosis (15.5%).
Participant milestones
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind)
Placebo - intravenous infusion over 60 minutes (±5 minutes).
|
Placebo (Double-blind) to CM-101 - 10mg/kg (Open-label)
Placebo during double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) 10mg/kg during open-label period Intravenous Infusion over 60 minutes (±5 minutes).
|
Placebo (Double-blind) to CM-101 - 20mg/kg (Open-label)
Placebo during double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) 20mg/kg during open-label period Intravenous Infusion over 60 minutes (±5 minutes).
|
|---|---|---|---|---|---|
|
Double-blind
STARTED
|
25
|
31
|
21
|
0
|
0
|
|
Double-blind
COMPLETED
|
22
|
29
|
19
|
0
|
0
|
|
Double-blind
NOT COMPLETED
|
3
|
2
|
2
|
0
|
0
|
|
Open-label
STARTED
|
11
|
27
|
0
|
1
|
11
|
|
Open-label
COMPLETED
|
6
|
25
|
0
|
0
|
11
|
|
Open-label
NOT COMPLETED
|
5
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CM-101 in PSC Patients -The SPRING Study
Baseline characteristics by cohort
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=25 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=31 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=21 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 15.19 • n=20 Participants
|
45.6 years
STANDARD_DEVIATION 10.27 • n=20 Participants
|
40.5 years
STANDARD_DEVIATION 12.84 • n=40 Participants
|
45.3 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
|
Time (years) since diagnosis of large duct PSC
|
6.4336 years
STANDARD_DEVIATION 6.8762 • n=20 Participants
|
8.284 years
STANDARD_DEVIATION 6.9798 • n=20 Participants
|
6.606 years
STANDARD_DEVIATION 6.1843 • n=40 Participants
|
7.235 years
STANDARD_DEVIATION 6.7141 • n=5 Participants
|
PRIMARY outcome
Timeframe: 15 week double-blind (DB) treatment periodPopulation: 76 patients analyzed in Safety Population as 1 patient discontinued prior to dosing.
Number of subjects with treatment-emergent adverse events (any, related, serious, and severe) - Safety-related endpoint
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=25 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=31 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=20 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Double-blind)
Severe TEAE
|
4 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Double-blind)
Any TEAE
|
18 Participants
|
28 Participants
|
15 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Double-blind)
Treatment-related TEAE
|
7 Participants
|
16 Participants
|
9 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Double-blind)
Serious TEAE
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: 33 week open-label (OL) treatment periodNumber of subjects with treatment-emergent adverse events (any, related, serious, and severe) - Safety-related endpoints
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=11 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=27 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=1 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
n=11 Participants
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Open-label)
Treatment-related TEAE
|
5 Participants
|
10 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Open-label)
Serious TEAE
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Open-label)
Severe TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Open-label)
Any TEAE
|
9 Participants
|
25 Participants
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 15 week double-blind (DB) treatment periodPopulation: 76 patients analyzed in Safety Population as 1 patient discontinued prior to dosing.
Number of subjects with Abnormal Vital Sign Changes - Safety-related endpoints
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=25 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=31 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=20 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Sign Changes (Double-blind)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 33 week open-label (OL) treatment periodNumber of subjects with abnormal vital sign changes - Safety-related endpoints
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=11 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=27 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=1 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
n=11 Participants
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Sign Changes (Open-label)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 15 week double-blind (DB) treatment periodPopulation: 76 patients analyzed in Safety Population as 1 patient discontinued prior to dosing.
Number of subjects with abnormal changes in Hematology, Clinical Chemistry, Coagulation Test, Lipid Test, and Urinalysis - Safety-related endpoints
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=25 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=31 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=20 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Double-blind)
Hematology
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Double-blind)
Clinical Chemistry
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Double-blind)
Coagulation Test
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Double-blind)
Lipid Test
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Double-blind)
Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 33 week open-label (OL) treatment periodNumber of subjects with abnormal changes in Hematology, Clinical Chemistry, Coagulation Test, Lipid Test, and Urinalysis - Safety-related endpoints
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=11 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=27 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=1 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
n=11 Participants
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Open-label)
Hematology
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Open-label)
Clinical Chemistry
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Open-label)
Coagulation Test
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Open-label)
Lipid Test
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Changes in Clinical Safety Laboratory Test Results (Open-label)
Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 15 week double-blind (DB) treatment periodPopulation: 76 patients analyzed in Safety Population as 1 patient discontinued prior to dosing.
Number of subjects with Infusion Site Reactions TEAEs - Safety-related endpoints
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=25 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=31 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=20 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Number of Participants With Infusion Site Reactions (Double-blind)
|
4 Participants
|
4 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 33 week open-label (OL) treatment periodNumber of subjects with Infusion Site Reactions TEAEs - Safety-related endpoints
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=11 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=27 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=1 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
n=11 Participants
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Number of Participants With Infusion Site Reactions (Open-label)
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Percent change from baseline to Week 15Population: 31 patients had baseline Fibroscan levels \<= 8.7 kPA
In subjects with baseline Fibroscan levels \<= 8.7 kPa, the percentage change of serum ALP levels at 15 weeks
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=8 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=14 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=9 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Percent Change in Serum ALP Levels (Baseline Pop. Fibroscan <= 8.7 kPa)
|
0.8 percentage change
Standard Deviation 17.31
|
-3.5 percentage change
Standard Deviation 31.06
|
-11.9 percentage change
Standard Deviation 21.22
|
—
|
SECONDARY outcome
Timeframe: Percent change from baseline to Week 15Population: 35 patients had baseline Fibroscan levels \> 8.7 kPa.
In subjects with baseline Fibroscan levels \> 8.7 kPa, the percentage change of serum ALP levels at 15 weeks
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=14 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=14 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=7 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Percent Change in Serum ALP Levels (Baseline Pop. Fibroscan > 8.7 kPa)
|
9.3 percentage change
Standard Deviation 30.13
|
-0.5 percentage change
Standard Deviation 17.39
|
11.3 percentage change
Standard Deviation 21.09
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline through Week 15The ELF™ test is a non-invasive blood test designed to evaluate liver fibrosis severity and predict the risk of progression to cirrhosis and liver-related events. The ELF score was validated in healthy control population and is only being evaluated in PSC as part of this clinical study. ELF measures 3 markers of liver fibrosis: 1) Hyaluronic Acid, 2) Type III Procollagen Amino-Terminal Peptide (PIIINP), 3) Tissue Inhibitor of Matrix Metalloproteinase 1 (TIMP-1). These markers combine to a unitless numeric ELF score using a validated algorithm, which reflects both fibrogenesis and fibrosis regression. The ELF score was interpreted using risk cut-offs established in other diseases to estimate the likelihood of progression to cirrhosis. There is no theoretical min or max for ELF score in PSC, but higher scores indicate greater fibrosis severity. Scores \< 9.8 indicate mild to moderate fibrosis while scores \>=9.8 suggest more severe fibrosis or cirrhosis.
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=22 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=27 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=18 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Enhanced Liver Fibrosis (ELF) by Treatment Group (MiTT)
|
9.951 Score
Standard Deviation 1.1187
|
9.807 Score
Standard Deviation 1.1836
|
9.719 Score
Standard Deviation 1.1075
|
—
|
SECONDARY outcome
Timeframe: Change from baseline through Week 15Population: ALP response rates were only available for 68 patients at Week 15
Subjects with ALP response rates, defined as reduction of ALP to 1.5 x upper limit of normal (ULN)
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=22 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=28 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=18 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
ALP Response Rates (<1.5 x ULN)
|
3 Participants
|
8 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Change from baseline through Week 15Population: ALP response rates were only available for 68 patients at Week 15
Subjects with ALP response rates, defined as reduction of ALP by greater than or equal to 20%
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=22 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=28 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=18 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
ALP Response Rates (>= 20% Reduction)
|
2 Participants
|
7 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Percent change from baseline through Week 15Population: ALT levels were only available for 67 patients at Week 15
The percentage change at 15 weeks in liver enzyme (alanine aminotransferase \[ALT\]))
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=22 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=28 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=17 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Percent Change in Liver Enzymes Levels (ALT)
|
23.0 percent
Standard Deviation 72.09
|
-5.9 percent
Standard Deviation 31.79
|
3.5 percent
Standard Deviation 30.81
|
—
|
SECONDARY outcome
Timeframe: Percent change from baseline through Week 15Population: ALT levels were only available for 67 patients at Week 15
The percentage change at 15 weeks in liver enzyme (aspartate aminotransferase \[AST\])
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=22 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=28 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=17 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Percent Change in Liver Enzymes Levels (AST)
|
19.2 percent
Standard Deviation 101.05
|
4.3 percent
Standard Deviation 49.51
|
10.8 percent
Standard Deviation 32.27
|
—
|
SECONDARY outcome
Timeframe: Percent change from baseline through Week 15Population: GGT levels were only available for 62 patients at Week 15
The percentage change at 15 weeks in liver enzyme (gamma glutamyl transferase \[GGT\])
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=18 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=26 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=18 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Percent Change in Liver Enzymes Levels (GGT)
|
14.9 percent
Standard Deviation 34.80
|
-3.1 percent
Standard Deviation 32.41
|
3.6 percent
Standard Deviation 41.62
|
—
|
SECONDARY outcome
Timeframe: Change from baseline through Week 15Population: Pro-C3 levels were only available for 67 patients at Week 15
The mean change at 15 weeks in liver enzyme (pro-peptide of type collagen \[PRO-C3\])
Outcome measures
| Measure |
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg
n=22 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg
n=27 Participants
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) to CM-101 - 10mg/kg or 20mg/kg (Open-label)
n=18 Participants
Placebo - intravenous infusion over 60 minutes (±5 minutes) in the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 10mg/kg or 20mg/kg - intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
Placebo (Double-blind), Then CM-101 - 20mg/kg (Open-label)
Placebo during the Double-blind period, then Anti-human CCL24 monoclonal antibody (CM-101) - 20mg/kg intravenous infusion over 60 minutes (±5 minutes) in the Open-label period.
|
|---|---|---|---|---|
|
Change in Liver Fibrosis Markers (PRO-C3)
|
-1.5 ng/mL
Standard Deviation 6.602
|
-0.22 ng/mL
Standard Deviation 12.906
|
1.97 ng/mL
Standard Deviation 7.006
|
—
|
Adverse Events
Placebo | Double-blind Period
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg | Double-blind Period
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg | Double-blind Period
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg | Open-label Period
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg | Open-label Period
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo (Double-blind) Then CM-101 - 10mg/kg | Open-label Period
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (Double-blind) Then CM-101 - 20mg/kg | Open-label Period
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo | Double-blind Period
n=20 participants at risk
Placebo - intravenous infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg | Double-blind Period
n=31 participants at risk
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg | Double-blind Period
n=25 participants at risk
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg | Open-label Period
n=11 participants at risk
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg | Open-label Period
n=27 participants at risk
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) Then CM-101 - 10mg/kg | Open-label Period
n=1 participants at risk
Placebo (control group) during 15-week double-blind period, then CM-101 (10mg/kg) during 33-weeks open-label period Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) Then CM-101 - 20mg/kg | Open-label Period
n=11 participants at risk
Placebo (control group) during 15-week double-blind period, then CM-101 (20mg/kg) during 33-weeks open-label period Intravenous Infusion over 60 minutes (±5 minutes)
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Obstructive Pancreatitis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
100.0%
1/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal disorders
Crohn's Disease
|
5.0%
1/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
Other adverse events
| Measure |
Placebo | Double-blind Period
n=20 participants at risk
Placebo - intravenous infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg | Double-blind Period
n=31 participants at risk
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg | Double-blind Period
n=25 participants at risk
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 10mg/kg | Open-label Period
n=11 participants at risk
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Anti-human CCL24 Monoclonal Antibody (CM-101) - 20mg/kg | Open-label Period
n=27 participants at risk
Anti-human CCL24 monoclonal antibody CM-101 Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) Then CM-101 - 10mg/kg | Open-label Period
n=1 participants at risk
Placebo (control group) during 15-week double-blind period, then CM-101 (10mg/kg) during 33-weeks open-label period Intravenous Infusion over 60 minutes (±5 minutes)
|
Placebo (Double-blind) Then CM-101 - 20mg/kg | Open-label Period
n=11 participants at risk
Placebo (control group) during 15-week double-blind period, then CM-101 (20mg/kg) during 33-weeks open-label period Intravenous Infusion over 60 minutes (±5 minutes)
|
|---|---|---|---|---|---|---|---|
|
Blood And Lymphatic System Disorders
Anaemia
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Cardiac Disorders
Palpitations
|
10.0%
2/20 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Eye Disorders
Iritis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
100.0%
1/1 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Abdominal Distension
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Abdominal Pain
|
10.0%
2/20 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
18.2%
2/11 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Abdominal Pain Upper
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
7.4%
2/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Colitis Ulcerative
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 4 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Crohn's Disease
|
10.0%
2/20 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Diarrhoea
|
10.0%
2/20 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.7%
3/31 • Number of events 5 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
14.8%
4/27 • Number of events 4 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Gastritis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Nausea
|
10.0%
2/20 • Number of events 4 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 6 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 9 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
18.2%
2/11 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Obstructive Pancreatitis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Rectal Haemorrhage
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Terminal Ileitis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Gastrointestinal Disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Asthenia
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 5 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Catheter Site Bruise
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Chills
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Fatigue
|
30.0%
6/20 • Number of events 8 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
38.7%
12/31 • Number of events 33 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
20.0%
5/25 • Number of events 8 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
29.6%
8/27 • Number of events 20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Feeling Hot
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Influenza Like Illness
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Infusion Site Erythema
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Infusion Site Pain
|
15.0%
3/20 • Number of events 4 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
12.0%
3/25 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Infusion Site Swelling
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Malaise
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Medical Device Site Swelling
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
General Disorders And Administration Site Conditions
Pyrexia
|
10.0%
2/20 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Hepatobiliary Disorders
Bile Duct Stenosis
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Hepatobiliary Disorders
Cholangitis
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
100.0%
1/1 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Hepatobiliary Disorders
Cholangitis Acute
|
5.0%
1/20 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Hepatobiliary Disorders
Hyperbilirubinaemia
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Hepatobiliary Disorders
Hypertransaminasaemia
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Hepatobiliary Disorders
Jaundice
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Immune System Disorders
Allergy To Arthropod Bite
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Immune System Disorders
Hypersensitivity
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Immune System Disorders
Seasonal Allergy
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Covid-19
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
27.3%
3/11 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Folliculitis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Gastroenteritis
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Influenza
|
10.0%
2/20 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.7%
3/31 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
7.4%
2/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
27.3%
3/11 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Nasopharyngitis
|
10.0%
2/20 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
12.9%
4/31 • Number of events 5 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
22.2%
6/27 • Number of events 8 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
18.2%
2/11 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Onychomycosis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Rhinitis
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Tonsillitis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Upper Respiratory Tract Infection
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
7.4%
2/27 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
18.2%
2/11 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Urinary Tract Infection
|
10.0%
2/20 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
12.0%
3/25 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Infections And Infestations
Wound Infection
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Injury, Poisoning And Procedural Complications
Arthropod Bite
|
5.0%
1/20 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Injury, Poisoning And Procedural Complications
Infusion Related Reaction
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Injury, Poisoning And Procedural Complications
Subdural Haematoma
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Investigations
Cardiac Murmur
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Investigations
Sars-Cov-2 Test Positive
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
12.0%
3/25 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Investigations
Weight Decreased
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Ankle Impingement
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Arthralgia
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
7.4%
2/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Arthritis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Back Pain
|
10.0%
2/20 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
6.5%
2/31 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Bursitis
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Musculoskeletal Pain
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Neck Pain
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Musculoskeletal And Connective Tissue Disorders
Osteoporosis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Nervous System Disorders
Dizziness
|
15.0%
3/20 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.7%
3/31 • Number of events 4 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
7.4%
2/27 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Nervous System Disorders
Headache
|
20.0%
4/20 • Number of events 8 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
29.0%
9/31 • Number of events 17 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
18.5%
5/27 • Number of events 16 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 4 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Nervous System Disorders
Lethargy
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Nervous System Disorders
Presyncope
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Nervous System Disorders
Tension Headache
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Psychiatric Disorders
Depression
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Psychiatric Disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Psychiatric Disorders
Poor Quality Sleep
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Renal And Urinary Disorders
Choluria
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Renal And Urinary Disorders
Dysuria
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Reproductive System And Breast Disorders
Haematospermia
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Reproductive System And Breast Disorders
Prostatitis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Cough
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
8.0%
2/25 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Nasal Congestion
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.7%
1/27 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Oropharyngeal Pain
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Throat Irritation
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
4.0%
1/25 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Skin And Subcutaneous Tissue Disorders
Actinic Keratosis
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Skin And Subcutaneous Tissue Disorders
Alopecia
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
7.4%
2/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Skin And Subcutaneous Tissue Disorders
Ingrowing Nail
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Skin And Subcutaneous Tissue Disorders
Pruritus
|
15.0%
3/20 • Number of events 4 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
12.9%
4/31 • Number of events 7 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
20.0%
5/25 • Number of events 10 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
18.2%
2/11 • Number of events 5 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
22.2%
6/27 • Number of events 6 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
27.3%
3/11 • Number of events 3 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Skin And Subcutaneous Tissue Disorders
Rash
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
3.2%
1/31 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
7.4%
2/27 • Number of events 2 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Skin And Subcutaneous Tissue Disorders
Rash Macular
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Skin And Subcutaneous Tissue Disorders
Skin Exfoliation
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Skin And Subcutaneous Tissue Disorders
Xanthelasma
|
0.00%
0/20 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
9.1%
1/11 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
|
Surgical And Medical Procedures
Wisdom Teeth Removal
|
5.0%
1/20 • Number of events 1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/31 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/25 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/27 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/1 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
0.00%
0/11 • The Double-blind Safety Population was defined by subjects receiving at least 1 of the planned 5 total IV administrations Q3W for 15 weeks (N=76). The Open-label Safety Population was defined by subjects receiving at least 1 dose of open-label study drug Q3W for 33 weeks (N=50), resulting in a combined total period of 48 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60