Trial Outcomes & Findings for A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) (NCT NCT00882999)
NCT ID: NCT00882999
Last Updated: 2018-11-15
Results Overview
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. To obtain the number of T1-weighted lesions per scan averaged during Weeks 12, 16, 20, and 24, the number of lesions per scan at each week was summed and then divided by the number of visits with non-missing lesion counts.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
245 participants
Primary outcome timeframe
Weeks 12, 16, 20, and 24
Results posted on
2018-11-15
Participant Flow
The study included 24 weeks of treatment and 24 weeks of follow-up. If necessary, participants had additional long-term follow-up for peripheral blood B cell monitoring (up to Week 108). Participants who completed study treatment (24 weeks) and the initial study follow-up (24 weeks) were considered study completers.
Participant milestones
| Measure |
4 mg LY2127399 Q4W
LY2127399: 4 milligrams (mg) subcutaneous injection once every 4 weeks (Q4W) for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection every 12 weeks (Q12W) for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks except (Weeks 0 and 12).
|
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks except (Weeks 0 and 12).
|
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
34
|
36
|
36
|
35
|
35
|
|
Overall Study
Received Any Amount of Study Drug
|
35
|
34
|
34
|
36
|
36
|
35
|
35
|
|
Overall Study
Completed Study Treatment
|
29
|
29
|
31
|
33
|
29
|
30
|
31
|
|
Overall Study
COMPLETED
|
27
|
26
|
30
|
31
|
28
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
4
|
5
|
8
|
7
|
8
|
Reasons for withdrawal
| Measure |
4 mg LY2127399 Q4W
LY2127399: 4 milligrams (mg) subcutaneous injection once every 4 weeks (Q4W) for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
LY2127399: 4 mg subcutaneous injection every 12 weeks (Q12W) for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks except (Weeks 0 and 12).
|
120 mg LY2127399 Q12W
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks except (Weeks 0 and 12).
|
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
3
|
3
|
6
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
2
|
1
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Baseline characteristics by cohort
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=34 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=34 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=35 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=35 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 10.06 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 10.78 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 11.10 • n=4 Participants
|
43.1 years
STANDARD_DEVIATION 10.62 • n=21 Participants
|
39.0 years
STANDARD_DEVIATION 10.16 • n=10 Participants
|
40.3 years
STANDARD_DEVIATION 12.02 • n=115 Participants
|
41.3 years
STANDARD_DEVIATION 10.69 • n=6 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
169 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
76 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
241 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
17 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
228 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
108 Participants
n=6 Participants
|
|
Region of Enrollment
Slovakia
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
32 Participants
n=6 Participants
|
|
Region of Enrollment
Ukraine
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
Russia
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
Czechia
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
|
Region of Enrollment
Hungary
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
|
Region of Enrollment
Poland
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
|
Region of Enrollment
Romania
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
|
Region of Enrollment
Bulgaria
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Region of Enrollment
Finland
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
Canada
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
|
Time Since Onset Of First Symptoms
|
8.5 years
STANDARD_DEVIATION 7.81 • n=5 Participants
|
9.4 years
STANDARD_DEVIATION 6.96 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 7.49 • n=5 Participants
|
8.9 years
STANDARD_DEVIATION 9.52 • n=4 Participants
|
7.8 years
STANDARD_DEVIATION 5.93 • n=21 Participants
|
9.2 years
STANDARD_DEVIATION 8.48 • n=10 Participants
|
7.4 years
STANDARD_DEVIATION 6.70 • n=115 Participants
|
8.6 years
STANDARD_DEVIATION 7.58 • n=6 Participants
|
|
Time Since First Diagnosis
|
5.9 years
STANDARD_DEVIATION 7.19 • n=5 Participants
|
6.3 years
STANDARD_DEVIATION 6.19 • n=7 Participants
|
5.4 years
STANDARD_DEVIATION 6.67 • n=5 Participants
|
5.0 years
STANDARD_DEVIATION 7.50 • n=4 Participants
|
5.0 years
STANDARD_DEVIATION 5.03 • n=21 Participants
|
6.0 years
STANDARD_DEVIATION 5.73 • n=10 Participants
|
3.8 years
STANDARD_DEVIATION 4.88 • n=115 Participants
|
5.3 years
STANDARD_DEVIATION 6.21 • n=6 Participants
|
|
Number Of Relapses In Past Year
|
1.4 relapses
STANDARD_DEVIATION 1.26 • n=5 Participants
|
1.3 relapses
STANDARD_DEVIATION 0.51 • n=7 Participants
|
1.4 relapses
STANDARD_DEVIATION 0.73 • n=5 Participants
|
1.2 relapses
STANDARD_DEVIATION 0.56 • n=4 Participants
|
1.4 relapses
STANDARD_DEVIATION 1.11 • n=21 Participants
|
1.5 relapses
STANDARD_DEVIATION 0.89 • n=10 Participants
|
1.5 relapses
STANDARD_DEVIATION 1.38 • n=115 Participants
|
1.4 relapses
STANDARD_DEVIATION 0.97 • n=6 Participants
|
|
Number of Gadolinium (Gd)-Enhancing T1-Weighted Lesions
|
1.1 lesions
STANDARD_DEVIATION 2.64 • n=5 Participants
|
0.5 lesions
STANDARD_DEVIATION 0.93 • n=7 Participants
|
1.1 lesions
STANDARD_DEVIATION 1.91 • n=5 Participants
|
1.4 lesions
STANDARD_DEVIATION 2.60 • n=4 Participants
|
1.3 lesions
STANDARD_DEVIATION 2.41 • n=21 Participants
|
1.2 lesions
STANDARD_DEVIATION 2.11 • n=10 Participants
|
1.2 lesions
STANDARD_DEVIATION 2.08 • n=115 Participants
|
1.1 lesions
STANDARD_DEVIATION 2.16 • n=6 Participants
|
|
Volume of T2-Weighted Lesions
|
8.5 milliliters (mL)
STANDARD_DEVIATION 10.53 • n=5 Participants
|
7.8 milliliters (mL)
STANDARD_DEVIATION 9.21 • n=7 Participants
|
6.6 milliliters (mL)
STANDARD_DEVIATION 7.92 • n=5 Participants
|
9.0 milliliters (mL)
STANDARD_DEVIATION 11.90 • n=4 Participants
|
10.1 milliliters (mL)
STANDARD_DEVIATION 13.90 • n=21 Participants
|
7.1 milliliters (mL)
STANDARD_DEVIATION 7.66 • n=10 Participants
|
7.0 milliliters (mL)
STANDARD_DEVIATION 8.07 • n=115 Participants
|
8.0 milliliters (mL)
STANDARD_DEVIATION 10.10 • n=6 Participants
|
PRIMARY outcome
Timeframe: Weeks 12, 16, 20, and 24Population: Randomized participants who had a Gd-enhancing T1-weighted MRI lesion for at least 1 time point among Weeks 12, 16, 20, or 24.
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. To obtain the number of T1-weighted lesions per scan averaged during Weeks 12, 16, 20, and 24, the number of lesions per scan at each week was summed and then divided by the number of visits with non-missing lesion counts.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=34 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=31 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=34 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=33 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Total Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan Averaged During Weeks 12, 16, 20, and 24
|
1.819 lesions per scan
Standard Deviation 3.312
|
0.710 lesions per scan
Standard Deviation 1.103
|
1.237 lesions per scan
Standard Deviation 1.999
|
1.477 lesions per scan
Standard Deviation 2.834
|
2.319 lesions per scan
Standard Deviation 4.145
|
1.422 lesions per scan
Standard Deviation 3.058
|
1.758 lesions per scan
Standard Deviation 3.615
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, and 48Population: Randomized participants who had a Gd-enhancing T1-weighted MRI assessment at the specified time points.
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of T1-weighted lesions per scan was obtained from the number of T1-weighted lesions observed during a specified week divided by the number of scans performed that same week. Least squares (LS) mean was calculated using an analysis of variance (ANOVA).
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=34 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=33 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=34 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=34 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 12
|
-0.1 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.11
|
-0.1 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.1 lesions per scan
Standard Error 0.10
|
-0.1 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.10
|
|
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 16
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.11
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.09
|
-0.0 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.10
|
|
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 20
|
-0.3 lesions per scan
Standard Error 0.10
|
-0.4 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.1 lesions per scan
Standard Error 0.09
|
-0.1 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.2 lesions per scan
Standard Error 0.09
|
|
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 24
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.4 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.3 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.2 lesions per scan
Standard Error 0.09
|
|
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 36
|
-0.3 lesions per scan
Standard Error 0.10
|
-0.4 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.2 lesions per scan
Standard Error 0.09
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.09
|
-0.2 lesions per scan
Standard Error 0.10
|
|
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 48
|
-0.4 lesions per scan
Standard Error 0.09
|
-0.5 lesions per scan
Standard Error 0.09
|
-0.4 lesions per scan
Standard Error 0.09
|
-0.3 lesions per scan
Standard Error 0.08
|
-0.4 lesions per scan
Standard Error 0.09
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.3 lesions per scan
Standard Error 0.10
|
|
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 4
|
-0.2 lesions per scan
Standard Error 0.09
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.3 lesions per scan
Standard Error 0.09
|
0.0 lesions per scan
Standard Error 0.09
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.1 lesions per scan
Standard Error 0.09
|
|
Change From Baseline in Number of Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 8
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.10
|
-0.3 lesions per scan
Standard Error 0.09
|
-0.0 lesions per scan
Standard Error 0.09
|
-0.2 lesions per scan
Standard Error 0.10
|
-0.2 lesions per scan
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 36, and 48Population: Randomized participants who had a Gd-enhancing T1-weighted MRI assessment at the specified time points.
Lesions were measured using Gd-enhancing T1-weighted MRI scans. The number of new T1-weighted lesions per scan was obtained from the number new T1-weighted lesions observed during a specified week divided by the number of scans performed that same week.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=34 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=33 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=34 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=34 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 4
|
1.1 lesions per scan
Standard Deviation 1.67
|
0.6 lesions per scan
Standard Deviation 1.09
|
0.6 lesions per scan
Standard Deviation 1.23
|
0.5 lesions per scan
Standard Deviation 1.11
|
1.9 lesions per scan
Standard Deviation 3.00
|
0.9 lesions per scan
Standard Deviation 1.71
|
1.4 lesions per scan
Standard Deviation 2.44
|
|
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 8
|
1.4 lesions per scan
Standard Deviation 2.52
|
0.6 lesions per scan
Standard Deviation 1.71
|
0.8 lesions per scan
Standard Deviation 1.48
|
0.5 lesions per scan
Standard Deviation 0.98
|
1.9 lesions per scan
Standard Deviation 3.91
|
2.2 lesions per scan
Standard Deviation 5.66
|
0.8 lesions per scan
Standard Deviation 1.59
|
|
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 12
|
1.4 lesions per scan
Standard Deviation 2.76
|
0.5 lesions per scan
Standard Deviation 0.96
|
1.3 lesions per scan
Standard Deviation 2.07
|
1.1 lesions per scan
Standard Deviation 2.73
|
1.4 lesions per scan
Standard Deviation 2.65
|
1.3 lesions per scan
Standard Deviation 2.30
|
1.3 lesions per scan
Standard Deviation 2.90
|
|
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 16
|
1.0 lesions per scan
Standard Deviation 1.72
|
0.6 lesions per scan
Standard Deviation 1.24
|
0.9 lesions per scan
Standard Deviation 1.89
|
1.0 lesions per scan
Standard Deviation 2.19
|
1.5 lesions per scan
Standard Deviation 2.92
|
1.1 lesions per scan
Standard Deviation 2.72
|
1.2 lesions per scan
Standard Deviation 3.32
|
|
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 20
|
0.8 lesions per scan
Standard Deviation 1.42
|
0.4 lesions per scan
Standard Deviation 0.88
|
0.9 lesions per scan
Standard Deviation 1.75
|
1.6 lesions per scan
Standard Deviation 3.03
|
1.0 lesions per scan
Standard Deviation 2.20
|
0.6 lesions per scan
Standard Deviation 1.54
|
1.1 lesions per scan
Standard Deviation 2.79
|
|
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 24
|
0.9 lesions per scan
Standard Deviation 2.51
|
0.5 lesions per scan
Standard Deviation 1.17
|
0.8 lesions per scan
Standard Deviation 1.33
|
1.4 lesions per scan
Standard Deviation 3.80
|
0.7 lesions per scan
Standard Deviation 1.74
|
0.9 lesions per scan
Standard Deviation 1.87
|
1.0 lesions per scan
Standard Deviation 2.52
|
|
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 36
|
0.7 lesions per scan
Standard Deviation 1.46
|
0.7 lesions per scan
Standard Deviation 1.67
|
1.1 lesions per scan
Standard Deviation 3.12
|
1.2 lesions per scan
Standard Deviation 2.30
|
1.4 lesions per scan
Standard Deviation 3.24
|
1.0 lesions per scan
Standard Deviation 2.34
|
0.9 lesions per scan
Standard Deviation 1.45
|
|
Total Number of New Gd-Enhancing T1-Weighted MRI Lesions Per Scan
Week 48
|
0.6 lesions per scan
Standard Deviation 1.50
|
0.2 lesions per scan
Standard Deviation 0.52
|
0.3 lesions per scan
Standard Deviation 0.72
|
1.0 lesions per scan
Standard Deviation 2.42
|
0.8 lesions per scan
Standard Deviation 2.40
|
1.1 lesions per scan
Standard Deviation 3.24
|
1.1 lesions per scan
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 36, and 48Population: Randomized participants who had a T2-weighted MRI assessment at the specified time points.
Lesions were measured using T2-weighted proton density MRI scans.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=34 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=33 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=34 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=34 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Week 12
|
1.7 lesions
Standard Deviation 3.35
|
1.1 lesions
Standard Deviation 1.88
|
1.3 lesions
Standard Deviation 2.01
|
1.3 lesions
Standard Deviation 2.85
|
2.0 lesions
Standard Deviation 3.66
|
1.9 lesions
Standard Deviation 3.45
|
1.7 lesions
Standard Deviation 3.51
|
|
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Week 16
|
1.2 lesions
Standard Deviation 2.07
|
1.0 lesions
Standard Deviation 1.85
|
1.4 lesions
Standard Deviation 2.73
|
1.5 lesions
Standard Deviation 3.10
|
1.8 lesions
Standard Deviation 3.49
|
1.7 lesions
Standard Deviation 4.12
|
1.5 lesions
Standard Deviation 4.23
|
|
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Week 36
|
1.5 lesions
Standard Deviation 2.55
|
1.6 lesions
Standard Deviation 3.02
|
2.4 lesions
Standard Deviation 4.27
|
2.8 lesions
Standard Deviation 5.18
|
3.0 lesions
Standard Deviation 6.64
|
2.8 lesions
Standard Deviation 4.69
|
1.6 lesions
Standard Deviation 3.31
|
|
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Week 4
|
1.5 lesions
Standard Deviation 2.21
|
0.7 lesions
Standard Deviation 1.39
|
0.7 lesions
Standard Deviation 1.46
|
0.9 lesions
Standard Deviation 1.66
|
2.1 lesions
Standard Deviation 3.48
|
1.4 lesions
Standard Deviation 2.47
|
2.0 lesions
Standard Deviation 3.28
|
|
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Week 8
|
1.5 lesions
Standard Deviation 2.60
|
0.9 lesions
Standard Deviation 2.23
|
1.0 lesions
Standard Deviation 1.69
|
0.7 lesions
Standard Deviation 1.13
|
2.4 lesions
Standard Deviation 4.42
|
2.8 lesions
Standard Deviation 6.88
|
1.2 lesions
Standard Deviation 2.21
|
|
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Week 20
|
0.9 lesions
Standard Deviation 1.66
|
0.8 lesions
Standard Deviation 1.70
|
1.2 lesions
Standard Deviation 2.16
|
2.1 lesions
Standard Deviation 4.40
|
1.6 lesions
Standard Deviation 4.06
|
1.0 lesions
Standard Deviation 1.88
|
1.4 lesions
Standard Deviation 4.20
|
|
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Week 24
|
1.0 lesions
Standard Deviation 2.37
|
0.7 lesions
Standard Deviation 1.51
|
1.2 lesions
Standard Deviation 2.42
|
1.7 lesions
Standard Deviation 4.28
|
1.0 lesions
Standard Deviation 2.40
|
1.3 lesions
Standard Deviation 2.79
|
1.5 lesions
Standard Deviation 3.52
|
|
Total Number of New or Newly Enlarging T2-Weighted MRI Lesions
Week 48
|
1.3 lesions
Standard Deviation 2.56
|
0.4 lesions
Standard Deviation 0.65
|
1.8 lesions
Standard Deviation 4.16
|
2.8 lesions
Standard Deviation 6.04
|
1.7 lesions
Standard Deviation 3.82
|
1.5 lesions
Standard Deviation 4.06
|
1.8 lesions
Standard Deviation 3.84
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 36, and 48Population: Randomized participants who had a T2-weighted MRI assessment at the specified time points.
The total volume of T2-weighted lesions was measured using T2-weighted proton density MRI scans. LS mean was calculated using an ANOVA model.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=34 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=33 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=34 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=34 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Total Volume of T2-Weighted MRI Lesions
Week 8
|
8.8 mL
Standard Error 1.74
|
8.0 mL
Standard Error 1.74
|
6.2 mL
Standard Error 1.80
|
9.0 mL
Standard Error 1.69
|
10.1 mL
Standard Error 1.67
|
7.3 mL
Standard Error 1.77
|
6.7 mL
Standard Error 1.72
|
|
Total Volume of T2-Weighted MRI Lesions
Week 48
|
6.6 mL
Standard Error 2.01
|
7.7 mL
Standard Error 2.05
|
7.0 mL
Standard Error 1.93
|
9.9 mL
Standard Error 1.84
|
11.5 mL
Standard Error 1.97
|
6.0 mL
Standard Error 2.05
|
4.6 mL
Standard Error 2.09
|
|
Total Volume of T2-Weighted MRI Lesions
Week 4
|
8.7 mL
Standard Error 1.73
|
7.6 mL
Standard Error 1.81
|
6.3 mL
Standard Error 1.81
|
8.7 mL
Standard Error 1.68
|
10.5 mL
Standard Error 1.71
|
6.8 mL
Standard Error 1.73
|
7.7 mL
Standard Error 1.73
|
|
Total Volume of T2-Weighted MRI Lesions
Week 12
|
8.8 mL
Standard Error 1.80
|
7.4 mL
Standard Error 1.92
|
6.3 mL
Standard Error 1.86
|
8.9 mL
Standard Error 1.72
|
10.1 mL
Standard Error 1.70
|
7.7 mL
Standard Error 1.83
|
6.7 mL
Standard Error 1.80
|
|
Total Volume of T2-Weighted MRI Lesions
Week 16
|
8.4 mL
Standard Error 1.79
|
7.3 mL
Standard Error 1.97
|
6.3 mL
Standard Error 1.87
|
8.6 mL
Standard Error 1.76
|
10.7 mL
Standard Error 1.84
|
7.6 mL
Standard Error 1.84
|
6.7 mL
Standard Error 1.84
|
|
Total Volume of T2-Weighted MRI Lesions
Week 20
|
7.0 mL
Standard Error 1.89
|
7.7 mL
Standard Error 1.86
|
6.4 mL
Standard Error 1.80
|
9.1 mL
Standard Error 1.69
|
10.4 mL
Standard Error 1.80
|
7.4 mL
Standard Error 1.74
|
6.8 mL
Standard Error 1.74
|
|
Total Volume of T2-Weighted MRI Lesions
Week 24
|
7.3 mL
Standard Error 1.91
|
7.7 mL
Standard Error 1.91
|
6.4 mL
Standard Error 1.88
|
9.7 mL
Standard Error 1.79
|
10.1 mL
Standard Error 1.91
|
7.7 mL
Standard Error 1.85
|
6.9 mL
Standard Error 1.82
|
|
Total Volume of T2-Weighted MRI Lesions
Week 36
|
7.1 mL
Standard Error 2.01
|
7.3 mL
Standard Error 2.01
|
6.8 mL
Standard Error 1.84
|
9.7 mL
Standard Error 1.81
|
11.5 mL
Standard Error 1.94
|
7.2 mL
Standard Error 1.84
|
6.6 mL
Standard Error 1.91
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: Randomized participants who had EDSS scores at the specified time points.
The EDSS is a rating scale for quantifying disability in multiple sclerosis (MS) participants. The EDSS has 8 functional systems (pyramidal, cerebellar, brain stem, sensory, bowel and bladder, visual, cerebral, and other) each rated on a scale from 0 (normal) to 5 (severe disability) or 0 (normal) to 6 (severe disability). The EDSS score was computed based on an algorithm of these components, and scores ranged from 0.0 (normal neurological exam) to 10.0 (death due to MS) in increments of 0.5.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=32 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=30 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=34 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=33 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Expanded Disability Status Scale (EDSS)
Week 24
|
2.91 units on a scale
Standard Deviation 0.992
|
2.78 units on a scale
Standard Deviation 1.334
|
2.62 units on a scale
Standard Deviation 1.250
|
2.17 units on a scale
Standard Deviation 1.429
|
2.64 units on a scale
Standard Deviation 1.625
|
2.82 units on a scale
Standard Deviation 1.283
|
2.77 units on a scale
Standard Deviation 1.419
|
|
Expanded Disability Status Scale (EDSS)
Week 12
|
2.96 units on a scale
Standard Deviation 1.146
|
2.75 units on a scale
Standard Deviation 1.397
|
2.65 units on a scale
Standard Deviation 1.212
|
2.17 units on a scale
Standard Deviation 1.493
|
2.54 units on a scale
Standard Deviation 1.490
|
2.54 units on a scale
Standard Deviation 1.395
|
2.47 units on a scale
Standard Deviation 1.457
|
|
Expanded Disability Status Scale (EDSS)
Week 48
|
2.96 units on a scale
Standard Deviation 1.263
|
2.46 units on a scale
Standard Deviation 1.612
|
2.74 units on a scale
Standard Deviation 1.066
|
2.18 units on a scale
Standard Deviation 1.568
|
2.57 units on a scale
Standard Deviation 1.505
|
2.73 units on a scale
Standard Deviation 1.357
|
2.60 units on a scale
Standard Deviation 1.377
|
SECONDARY outcome
Timeframe: Baseline through Week 24, Baseline through Week 48, and Week 24 through Week 48Population: Randomized participants who had a relapse assessment for the specified time periods. Twenty-one (21), 24, 24, 28, 23, 26, and 26 participants were censored in the following arms respectively: 4 mg, 12 mg, 40 mg, and 120 mg LY2127399 Q4W, 4 mg and 120 mg LY2127399 Q12W, and placebo.
A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. If a relapse did not occur during the specified time frame, the time to the first confirmed relapse was censored to the date of the participant's last available visit at or prior to Week 24, Week 48, and Week 48 for the respective time frames.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=34 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=33 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=35 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=35 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Time to First Relapse
Week 24 through Week 48
|
144.38 days
Standard Deviation 46.900
|
144.46 days
Standard Deviation 49.736
|
154.33 days
Standard Deviation 51.892
|
163.39 days
Standard Deviation 22.685
|
150.32 days
Standard Deviation 36.685
|
148.07 days
Standard Deviation 51.075
|
161.23 days
Standard Deviation 16.346
|
|
Time to First Relapse
Baseline through Week 24
|
139.54 days
Standard Deviation 48.949
|
141.56 days
Standard Deviation 51.460
|
154.73 days
Standard Deviation 40.117
|
153.72 days
Standard Deviation 32.753
|
140.06 days
Standard Deviation 53.970
|
151.23 days
Standard Deviation 40.717
|
148.37 days
Standard Deviation 49.911
|
|
Time to First Relapse
Baseline through Week 48
|
243.57 days
Standard Deviation 119.991
|
242.68 days
Standard Deviation 123.805
|
286.85 days
Standard Deviation 99.004
|
279.17 days
Standard Deviation 100.955
|
241.97 days
Standard Deviation 119.871
|
272.23 days
Standard Deviation 105.653
|
276.46 days
Standard Deviation 112.039
|
SECONDARY outcome
Timeframe: Week 24, Week 48, end of study treatment [Week 24 or early discontinuation (ED)], and end of follow-up (Week 48 or ED)Population: Randomized participants who had a relapse assessment at the specified time points.
A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may not have required systemic corticosteroid treatment. Percentage of relapse-free participants=\[(number of participants who did not relapse)/(number of pts assessed)\]\*100.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=34 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=33 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=35 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=35 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Relapse-Free Participants
Week 24
|
72.4 percentage of participants
|
82.8 percentage of participants
|
77.4 percentage of participants
|
84.8 percentage of participants
|
79.3 percentage of participants
|
83.9 percentage of participants
|
83.9 percentage of participants
|
|
Percentage of Relapse-Free Participants
Week 48
|
70.4 percentage of participants
|
73.1 percentage of participants
|
64.5 percentage of participants
|
75.0 percentage of participants
|
67.9 percentage of participants
|
72.4 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Relapse-Free Participants
End of Treatment
|
74.3 percentage of participants
|
76.5 percentage of participants
|
78.8 percentage of participants
|
83.3 percentage of participants
|
75.0 percentage of participants
|
80.0 percentage of participants
|
82.9 percentage of participants
|
|
Percentage of Relapse-Free Participants
End of Follow-Up
|
68.6 percentage of participants
|
67.6 percentage of participants
|
66.7 percentage of participants
|
77.8 percentage of participants
|
63.9 percentage of participants
|
65.7 percentage of participants
|
77.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 24 and Baseline through Week 48Population: Randomized participants who had a relapse assessment for the specified time periods.
The number of confirmed relapses per year, ARR=\[(number of relapses from baseline through Week 24 or baseline through Week 48)/(the time in days between the same interval)\]\*365.25. A confirmed relapse was defined as the appearance of 1 or more new neurological symptom(s) attributable to MS or the worsening of 1 or more previously observed symptoms. This change in clinical state was to last at least 48 hours and be immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. New or worsening neurological symptoms were accompanied by objective EDSS changes on examination (an increase from baseline of at least 1 point on the EDSS, at least 1 point on 2 EDSS functional systems, or at least 2 points on 1 EDSS functional system). A relapse may or may have not required systemic corticosteroid treatment.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=34 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=33 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=35 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=35 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Annualized Relapse Rate (ARR) at Week 24 and Week 48
Week 24
|
0.75 relapses per year
Standard Deviation 1.568
|
0.80 relapses per year
Standard Deviation 1.830
|
0.33 relapses per year
Standard Deviation 0.787
|
0.38 relapses per year
Standard Deviation 0.856
|
0.67 relapses per year
Standard Deviation 1.536
|
0.51 relapses per year
Standard Deviation 1.205
|
0.71 relapses per year
Standard Deviation 2.844
|
|
Annualized Relapse Rate (ARR) at Week 24 and Week 48
Week 48
|
0.67 relapses per year
Standard Deviation 1.463
|
0.64 relapses per year
Standard Deviation 1.284
|
0.36 relapses per year
Standard Deviation 0.645
|
0.24 relapses per year
Standard Deviation 0.461
|
0.56 relapses per year
Standard Deviation 0.966
|
0.53 relapses per year
Standard Deviation 0.936
|
0.66 relapses per year
Standard Deviation 2.805
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: Randomized participants who had MSFC scores at the specified time points.
The MSFC is a composite scale consisting of 3 components \[Timed 25-Foot Walk, 9-Hole Peg Test (9-HPT), and 3-Second Paced Auditory Serial Addition Test (PASAT-3)\]. The Timed 25-Foot Walk was a quantitative measure of lower extremity function. The 9-HPT was a quantitative measure of upper extremity (arm and hand) function. The PASAT-3 was a measure of cognitive function that specifically assessed auditory information processing speed and flexibility, as well as calculation ability. Component scores ranged from 0 to 60 and were converted to standard scores (z-scores). The MSFC score was calculated as the average of the 3 standardized component scores. Higher MSFC scores reflected better neurological function.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=32 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=35 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=34 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=34 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=32 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Multiple Sclerosis Functional Composite Scale (MSFC)
Week 12
|
0.11 units on a scale
Standard Deviation 0.821
|
0.08 units on a scale
Standard Deviation 0.511
|
-0.02 units on a scale
Standard Deviation 0.385
|
0.06 units on a scale
Standard Deviation 0.396
|
-0.02 units on a scale
Standard Deviation 0.471
|
0.26 units on a scale
Standard Deviation 0.870
|
0.39 units on a scale
Standard Deviation 0.955
|
|
Multiple Sclerosis Functional Composite Scale (MSFC)
Week 24
|
0.05 units on a scale
Standard Deviation 0.741
|
0.11 units on a scale
Standard Deviation 0.461
|
0.02 units on a scale
Standard Deviation 0.369
|
0.17 units on a scale
Standard Deviation 0.547
|
-0.06 units on a scale
Standard Deviation 0.316
|
0.15 units on a scale
Standard Deviation 0.707
|
0.24 units on a scale
Standard Deviation 0.606
|
|
Multiple Sclerosis Functional Composite Scale (MSFC)
Week 48
|
-0.11 units on a scale
Standard Deviation 0.504
|
0.07 units on a scale
Standard Deviation 0.471
|
0.04 units on a scale
Standard Deviation 0.350
|
0.08 units on a scale
Standard Deviation 0.332
|
0.03 units on a scale
Standard Deviation 0.321
|
0.10 units on a scale
Standard Deviation 0.388
|
0.13 units on a scale
Standard Deviation 0.344
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: Randomized participants who had VAS of Wellbeing scores at the specified time points.
The VAS is a 100-millimeter (mm) horizontal line marked with 0 mm = "poor" and 100 mm = "excellent." Participants were asked to assess their wellbeing by making a vertical mark on the scale. The score was computed as the distance from 0 mm to the vertical mark.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=32 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=33 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=33 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Visual Analog Scale (VAS) of Wellbeing
Week 12
|
55.86 mm
Standard Deviation 24.686
|
61.09 mm
Standard Deviation 20.934
|
63.20 mm
Standard Deviation 24.864
|
65.78 mm
Standard Deviation 24.114
|
59.67 mm
Standard Deviation 21.511
|
64.67 mm
Standard Deviation 22.235
|
60.18 mm
Standard Deviation 20.430
|
|
Visual Analog Scale (VAS) of Wellbeing
Week 24
|
58.86 mm
Standard Deviation 22.874
|
54.79 mm
Standard Deviation 23.665
|
63.26 mm
Standard Deviation 18.630
|
61.42 mm
Standard Deviation 23.829
|
57.76 mm
Standard Deviation 23.257
|
60.84 mm
Standard Deviation 23.602
|
55.70 mm
Standard Deviation 26.785
|
|
Visual Analog Scale (VAS) of Wellbeing
Week 48
|
59.77 mm
Standard Deviation 26.288
|
56.19 mm
Standard Deviation 26.872
|
62.93 mm
Standard Deviation 25.201
|
65.29 mm
Standard Deviation 24.487
|
52.71 mm
Standard Deviation 23.434
|
56.39 mm
Standard Deviation 26.720
|
64.48 mm
Standard Deviation 24.985
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: Randomized participants who had QIDS-SR16 scores at the specified time points.
The QIDS-SR16 is a 16-item participant-rated measure of depressive symptomatology. Each item corresponds to 1 of 9 criterion domains for depression: change in sleep disturbance \[question (Q) 1 through Q4\], sad mood (Q5), decrease or increase in appetite and weight (Q6 through Q9), concentration (Q10), self-criticism (Q11), suicidal ideation (Q12), interest (Q13), energy/fatigue (Q14), and psychomotor agitation and retardation (Q15 and Q16). Each question was scored 0 (no problems) to 3 (increased symptoms). The total score=(the highest score from Q1 through Q4)+(Q5 score)+(the highest score from Q6 through Q9)+(the total score for each Q10 through Q14)+(the highest score from Q15 and Q16). A total score of 0 through 5 was considered no depression likely, 6 through 10 was mild depression, 11 through 15 was moderate depression, 16 through 20 was severe depression, and 21 or over was very severe depression.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=34 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=32 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=33 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=32 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)
Week 12
|
7.79 units on a scale
Standard Deviation 4.766
|
6.78 units on a scale
Standard Deviation 4.668
|
7.13 units on a scale
Standard Deviation 5.322
|
5.94 units on a scale
Standard Deviation 3.695
|
7.47 units on a scale
Standard Deviation 3.676
|
6.42 units on a scale
Standard Deviation 4.000
|
7.38 units on a scale
Standard Deviation 4.577
|
|
16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)
Week 24
|
7.25 units on a scale
Standard Deviation 5.082
|
6.43 units on a scale
Standard Deviation 4.717
|
6.52 units on a scale
Standard Deviation 3.906
|
6.30 units on a scale
Standard Deviation 4.660
|
7.21 units on a scale
Standard Deviation 3.867
|
6.84 units on a scale
Standard Deviation 3.934
|
6.23 units on a scale
Standard Deviation 3.441
|
|
16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16)
Week 48
|
6.38 units on a scale
Standard Deviation 4.491
|
5.54 units on a scale
Standard Deviation 3.723
|
6.82 units on a scale
Standard Deviation 5.143
|
5.74 units on a scale
Standard Deviation 3.651
|
7.68 units on a scale
Standard Deviation 5.004
|
7.43 units on a scale
Standard Deviation 4.272
|
6.20 units on a scale
Standard Deviation 4.537
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and 48Population: Randomized participants who had SF-36 component scores at the specified time points.
The SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores were calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status or function. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100).
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=32 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=31 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=33 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=33 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
PCS, Week 48
|
44.17 units on a scale
Standard Deviation 10.496
|
43.21 units on a scale
Standard Deviation 9.144
|
42.43 units on a scale
Standard Deviation 9.400
|
47.72 units on a scale
Standard Deviation 9.593
|
42.59 units on a scale
Standard Deviation 9.011
|
41.22 units on a scale
Standard Deviation 12.093
|
44.78 units on a scale
Standard Deviation 10.020
|
|
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
MCS, Week 48
|
46.40 units on a scale
Standard Deviation 11.290
|
49.69 units on a scale
Standard Deviation 9.131
|
45.66 units on a scale
Standard Deviation 12.016
|
47.89 units on a scale
Standard Deviation 13.543
|
44.75 units on a scale
Standard Deviation 11.838
|
46.03 units on a scale
Standard Deviation 10.618
|
46.85 units on a scale
Standard Deviation 10.793
|
|
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
PCS, Week 12
|
40.96 units on a scale
Standard Deviation 10.673
|
45.53 units on a scale
Standard Deviation 9.511
|
44.30 units on a scale
Standard Deviation 10.298
|
45.57 units on a scale
Standard Deviation 10.716
|
42.80 units on a scale
Standard Deviation 9.638
|
42.29 units on a scale
Standard Deviation 9.962
|
43.12 units on a scale
Standard Deviation 11.656
|
|
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
MCS, Week 12
|
42.86 units on a scale
Standard Deviation 11.410
|
43.94 units on a scale
Standard Deviation 10.736
|
44.62 units on a scale
Standard Deviation 13.547
|
48.62 units on a scale
Standard Deviation 11.023
|
44.10 units on a scale
Standard Deviation 11.675
|
49.08 units on a scale
Standard Deviation 9.108
|
46.93 units on a scale
Standard Deviation 9.889
|
|
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
PCS, Week 24
|
44.08 units on a scale
Standard Deviation 9.421
|
44.22 units on a scale
Standard Deviation 8.118
|
41.66 units on a scale
Standard Deviation 9.927
|
46.30 units on a scale
Standard Deviation 9.862
|
44.10 units on a scale
Standard Deviation 9.766
|
43.11 units on a scale
Standard Deviation 9.890
|
43.81 units on a scale
Standard Deviation 10.568
|
|
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
MCS, Week 24
|
44.20 units on a scale
Standard Deviation 11.836
|
46.95 units on a scale
Standard Deviation 10.270
|
46.20 units on a scale
Standard Deviation 10.405
|
47.48 units on a scale
Standard Deviation 13.101
|
44.90 units on a scale
Standard Deviation 11.217
|
46.52 units on a scale
Standard Deviation 10.661
|
46.29 units on a scale
Standard Deviation 10.150
|
SECONDARY outcome
Timeframe: Week 0: Day 1, 2, or 3 and Weeks 1, 4, 8, 12, 16, 20, 24, 30, 36, and 40.Population: Randomized participants who had evaluable PK data.
AUCtau,ss was obtained by conducting a simulation consisting of 1000 participants, which were then used to determine the noncompartmental PK parameters for each regimen.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=34 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=33 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=36 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=35 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss)
|
161 micrograms/milliliter*hours (mcg/mL*h)
Standard Deviation 127
|
724 micrograms/milliliter*hours (mcg/mL*h)
Standard Deviation 569
|
4405 micrograms/milliliter*hours (mcg/mL*h)
Standard Deviation 2010
|
16603 micrograms/milliliter*hours (mcg/mL*h)
Standard Deviation 5444
|
146 micrograms/milliliter*hours (mcg/mL*h)
Standard Deviation 108
|
13608 micrograms/milliliter*hours (mcg/mL*h)
Standard Deviation 5746
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 48, 60, 72, 84, 96, and 108Population: Randomized participants who had an ADA assessment at the specified time periods.
The percentage of participants with ADA=\[(number of participants who had ADA)/(number of participants assessed)\]\*100.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=35 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=33 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=33 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=34 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=36 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=35 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=35 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Baseline, Positive ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 4, Positive ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 12, Positive ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 24, Positive ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 48, Positive ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 60, Positive ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 72, Positive ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 84, Positive ADA
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 96, Positive ADA
|
—
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-LY2127399 Antibodies [Anti-Drug Antibodies (ADA)]
Week 108, Positive ADA
|
—
|
—
|
—
|
0 percentage of participants
|
—
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—
|
—
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SECONDARY outcome
Timeframe: Baseline, Day 2, Weeks (Wks) 1, 4, 12, 24, 36, and 48Population: Randomized participants who had peripheral blood B cell subset cell counts at the specified time points.
Cell surface marker cluster designation (CD)19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive B cells (CD19+IgD+CD27-); immature/transitional (immature/tran) B cells (CD19+IgD-CD27-); switched memory B cells (CD19+IgD-CD27+); and non-switched memory B cells (CD19+IgD+CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count.
Outcome measures
| Measure |
4 mg LY2127399 Q4W
n=28 Participants
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W
n=29 Participants
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W
n=29 Participants
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W
n=32 Participants
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W
n=32 Participants
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W
n=30 Participants
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo
n=30 Participants
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Tran, Wk 36
|
1.5 cells per microliter (cells/µL)
Standard Deviation 8.7
|
0.1 cells per microliter (cells/µL)
Standard Deviation 6.2
|
-3.7 cells per microliter (cells/µL)
Standard Deviation 3.8
|
-2.9 cells per microliter (cells/µL)
Standard Deviation 7.7
|
1.8 cells per microliter (cells/µL)
Standard Deviation 7.5
|
-9.2 cells per microliter (cells/µL)
Standard Deviation 26.4
|
1.4 cells per microliter (cells/µL)
Standard Deviation 3.6
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive, Day 2
|
18.2 cells per microliter (cells/µL)
Standard Deviation 51.9
|
23.8 cells per microliter (cells/µL)
Standard Deviation 35.7
|
26.9 cells per microliter (cells/µL)
Standard Deviation 89.3
|
28.3 cells per microliter (cells/µL)
Standard Deviation 93.4
|
18.6 cells per microliter (cells/µL)
Standard Deviation 49.3
|
16.3 cells per microliter (cells/µL)
Standard Deviation 69.7
|
-23.5 cells per microliter (cells/µL)
Standard Deviation 68.3
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive, Wk 1
|
13.7 cells per microliter (cells/µL)
Standard Deviation 71.3
|
30.2 cells per microliter (cells/µL)
Standard Deviation 69.5
|
27.8 cells per microliter (cells/µL)
Standard Deviation 64.3
|
13.8 cells per microliter (cells/µL)
Standard Deviation 83.0
|
38.5 cells per microliter (cells/µL)
Standard Deviation 51.1
|
30.2 cells per microliter (cells/µL)
Standard Deviation 74.1
|
-0.9 cells per microliter (cells/µL)
Standard Deviation 49.2
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive, Wk 4
|
-24.7 cells per microliter (cells/µL)
Standard Deviation 84.7
|
-48.0 cells per microliter (cells/µL)
Standard Deviation 49.5
|
-54.8 cells per microliter (cells/µL)
Standard Deviation 62.0
|
-54.9 cells per microliter (cells/µL)
Standard Deviation 80.1
|
-18.9 cells per microliter (cells/µL)
Standard Deviation 30.9
|
-73.5 cells per microliter (cells/µL)
Standard Deviation 69.7
|
-10.4 cells per microliter (cells/µL)
Standard Deviation 69.7
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive, Wk 12
|
-55.9 cells per microliter (cells/µL)
Standard Deviation 68.7
|
-77.0 cells per microliter (cells/µL)
Standard Deviation 57.0
|
-116.9 cells per microliter (cells/µL)
Standard Deviation 115.0
|
-108.5 cells per microliter (cells/µL)
Standard Deviation 97.4
|
-4.2 cells per microliter (cells/µL)
Standard Deviation 42.3
|
-130.4 cells per microliter (cells/µL)
Standard Deviation 105.4
|
5.2 cells per microliter (cells/µL)
Standard Deviation 82.8
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive, Wk 24
|
-83.0 cells per microliter (cells/µL)
Standard Deviation 93.3
|
-92.7 cells per microliter (cells/µL)
Standard Deviation 72.8
|
-143.9 cells per microliter (cells/µL)
Standard Deviation 127.2
|
-122.9 cells per microliter (cells/µL)
Standard Deviation 102.3
|
-9.0 cells per microliter (cells/µL)
Standard Deviation 62.9
|
-149.9 cells per microliter (cells/µL)
Standard Deviation 125.5
|
10.0 cells per microliter (cells/µL)
Standard Deviation 124.5
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive, Wk 36
|
-40.4 cells per microliter (cells/µL)
Standard Deviation 106.1
|
-78.9 cells per microliter (cells/µL)
Standard Deviation 78.9
|
-147.0 cells per microliter (cells/µL)
Standard Deviation 134.9
|
-130.7 cells per microliter (cells/µL)
Standard Deviation 102.3
|
-3.0 cells per microliter (cells/µL)
Standard Deviation 66.7
|
-118.3 cells per microliter (cells/µL)
Standard Deviation 131.8
|
9.7 cells per microliter (cells/µL)
Standard Deviation 99.9
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Mature Naive, Wk 48
|
-7.0 cells per microliter (cells/µL)
Standard Deviation 119.3
|
-65.7 cells per microliter (cells/µL)
Standard Deviation 101.4
|
-118.0 cells per microliter (cells/µL)
Standard Deviation 136.6
|
-130.6 cells per microliter (cells/µL)
Standard Deviation 110.5
|
1.5 cells per microliter (cells/µL)
Standard Deviation 69.9
|
-92.7 cells per microliter (cells/µL)
Standard Deviation 133.0
|
-5.5 cells per microliter (cells/µL)
Standard Deviation 59.9
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Tran, Day 2
|
2.3 cells per microliter (cells/µL)
Standard Deviation 5.4
|
2.0 cells per microliter (cells/µL)
Standard Deviation 6.0
|
0.5 cells per microliter (cells/µL)
Standard Deviation 3.7
|
0.1 cells per microliter (cells/µL)
Standard Deviation 6.8
|
1.4 cells per microliter (cells/µL)
Standard Deviation 4.5
|
-4.9 cells per microliter (cells/µL)
Standard Deviation 25.9
|
0.1 cells per microliter (cells/µL)
Standard Deviation 3.5
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Tran, Wk 1
|
3.7 cells per microliter (cells/µL)
Standard Deviation 10.5
|
1.8 cells per microliter (cells/µL)
Standard Deviation 7.1
|
3.4 cells per microliter (cells/µL)
Standard Deviation 8.5
|
1.9 cells per microliter (cells/µL)
Standard Deviation 9.5
|
3.2 cells per microliter (cells/µL)
Standard Deviation 5.3
|
-3.8 cells per microliter (cells/µL)
Standard Deviation 27.6
|
-0.3 cells per microliter (cells/µL)
Standard Deviation 4.7
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Tran, Wk 4
|
1.0 cells per microliter (cells/µL)
Standard Deviation 5.5
|
0.9 cells per microliter (cells/µL)
Standard Deviation 7.0
|
3.8 cells per microliter (cells/µL)
Standard Deviation 13.2
|
-0.6 cells per microliter (cells/µL)
Standard Deviation 4.4
|
0.2 cells per microliter (cells/µL)
Standard Deviation 4.0
|
-4.8 cells per microliter (cells/µL)
Standard Deviation 25.1
|
3.3 cells per microliter (cells/µL)
Standard Deviation 13.3
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Tran Wk 12
|
-0.4 cells per microliter (cells/µL)
Standard Deviation 5.2
|
0.2 cells per microliter (cells/µL)
Standard Deviation 8.3
|
-1.0 cells per microliter (cells/µL)
Standard Deviation 4.4
|
-2.0 cells per microliter (cells/µL)
Standard Deviation 6.1
|
-0.2 cells per microliter (cells/µL)
Standard Deviation 4.3
|
-6.4 cells per microliter (cells/µL)
Standard Deviation 26.0
|
2.0 cells per microliter (cells/µL)
Standard Deviation 7.6
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Tran Wk 24
|
2.0 cells per microliter (cells/µL)
Standard Deviation 6.4
|
-0.3 cells per microliter (cells/µL)
Standard Deviation 9.0
|
-1.7 cells per microliter (cells/µL)
Standard Deviation 4.3
|
-2.8 cells per microliter (cells/µL)
Standard Deviation 6.9
|
1.4 cells per microliter (cells/µL)
Standard Deviation 10.8
|
-8.3 cells per microliter (cells/µL)
Standard Deviation 29.5
|
0.4 cells per microliter (cells/µL)
Standard Deviation 4.3
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Immature/Tran, Wk 48
|
2.9 cells per microliter (cells/µL)
Standard Deviation 8.8
|
1.8 cells per microliter (cells/µL)
Standard Deviation 8.9
|
-2.0 cells per microliter (cells/µL)
Standard Deviation 5.1
|
-4.0 cells per microliter (cells/µL)
Standard Deviation 9.5
|
9.1 cells per microliter (cells/µL)
Standard Deviation 21.8
|
-10.3 cells per microliter (cells/µL)
Standard Deviation 28.0
|
1.3 cells per microliter (cells/µL)
Standard Deviation 6.1
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory, Day 2
|
14.2 cells per microliter (cells/µL)
Standard Deviation 19.3
|
8.0 cells per microliter (cells/µL)
Standard Deviation 19.7
|
8.1 cells per microliter (cells/µL)
Standard Deviation 11.8
|
0.5 cells per microliter (cells/µL)
Standard Deviation 30.5
|
5.5 cells per microliter (cells/µL)
Standard Deviation 12.9
|
7.9 cells per microliter (cells/µL)
Standard Deviation 17.2
|
0.1 cells per microliter (cells/µL)
Standard Deviation 15.0
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory, Wk 1
|
27.1 cells per microliter (cells/µL)
Standard Deviation 25.9
|
26.0 cells per microliter (cells/µL)
Standard Deviation 24.8
|
26.9 cells per microliter (cells/µL)
Standard Deviation 27.7
|
15.0 cells per microliter (cells/µL)
Standard Deviation 31.0
|
21.8 cells per microliter (cells/µL)
Standard Deviation 18.9
|
28.2 cells per microliter (cells/µL)
Standard Deviation 30.5
|
2.0 cells per microliter (cells/µL)
Standard Deviation 19.2
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory, Wk 4
|
12.5 cells per microliter (cells/µL)
Standard Deviation 31.6
|
20.5 cells per microliter (cells/µL)
Standard Deviation 19.7
|
28.6 cells per microliter (cells/µL)
Standard Deviation 26.3
|
18.9 cells per microliter (cells/µL)
Standard Deviation 30.7
|
-0.1 cells per microliter (cells/µL)
Standard Deviation 18.1
|
31.9 cells per microliter (cells/µL)
Standard Deviation 30.0
|
0.7 cells per microliter (cells/µL)
Standard Deviation 20.3
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory, Wk 12
|
7.0 cells per microliter (cells/µL)
Standard Deviation 16.4
|
23.5 cells per microliter (cells/µL)
Standard Deviation 20.9
|
26.2 cells per microliter (cells/µL)
Standard Deviation 22.8
|
22.1 cells per microliter (cells/µL)
Standard Deviation 22.3
|
-1.9 cells per microliter (cells/µL)
Standard Deviation 16.0
|
15.8 cells per microliter (cells/µL)
Standard Deviation 30.0
|
5.4 cells per microliter (cells/µL)
Standard Deviation 28.3
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory, Wk 24
|
12.3 cells per microliter (cells/µL)
Standard Deviation 32.8
|
24.5 cells per microliter (cells/µL)
Standard Deviation 26.4
|
23.8 cells per microliter (cells/µL)
Standard Deviation 23.4
|
16.8 cells per microliter (cells/µL)
Standard Deviation 31.0
|
8.9 cells per microliter (cells/µL)
Standard Deviation 22.8
|
17.4 cells per microliter (cells/µL)
Standard Deviation 31.3
|
3.0 cells per microliter (cells/µL)
Standard Deviation 25.3
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory, Wk 36
|
8.9 cells per microliter (cells/µL)
Standard Deviation 63.2
|
-10.3 cells per microliter (cells/µL)
Standard Deviation 21.1
|
-9.1 cells per microliter (cells/µL)
Standard Deviation 15.6
|
6.5 cells per microliter (cells/µL)
Standard Deviation 41.0
|
-1.0 cells per microliter (cells/µL)
Standard Deviation 24.5
|
-18.7 cells per microliter (cells/µL)
Standard Deviation 26.4
|
1.5 cells per microliter (cells/µL)
Standard Deviation 16.6
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Switched Memory, Wk 48
|
15.0 cells per microliter (cells/µL)
Standard Deviation 45.9
|
-7.3 cells per microliter (cells/µL)
Standard Deviation 33.6
|
-13.0 cells per microliter (cells/µL)
Standard Deviation 18.3
|
-20.4 cells per microliter (cells/µL)
Standard Deviation 38.7
|
11.0 cells per microliter (cells/µL)
Standard Deviation 40.0
|
-16.9 cells per microliter (cells/µL)
Standard Deviation 36.2
|
-4.1 cells per microliter (cells/µL)
Standard Deviation 25.1
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory, Day 2
|
7.7 cells per microliter (cells/µL)
Standard Deviation 13.4
|
3.8 cells per microliter (cells/µL)
Standard Deviation 10.7
|
11.4 cells per microliter (cells/µL)
Standard Deviation 17.8
|
9.0 cells per microliter (cells/µL)
Standard Deviation 14.2
|
6.7 cells per microliter (cells/µL)
Standard Deviation 19.5
|
7.8 cells per microliter (cells/µL)
Standard Deviation 18.0
|
0.6 cells per microliter (cells/µL)
Standard Deviation 10.8
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory, Wk 1
|
12.3 cells per microliter (cells/µL)
Standard Deviation 15.9
|
20.3 cells per microliter (cells/µL)
Standard Deviation 30.4
|
19.4 cells per microliter (cells/µL)
Standard Deviation 14.9
|
16.6 cells per microliter (cells/µL)
Standard Deviation 14.9
|
15.4 cells per microliter (cells/µL)
Standard Deviation 18.6
|
18.3 cells per microliter (cells/µL)
Standard Deviation 15.9
|
4.1 cells per microliter (cells/µL)
Standard Deviation 13.2
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory, Wk 4
|
3.2 cells per microliter (cells/µL)
Standard Deviation 17.6
|
13.8 cells per microliter (cells/µL)
Standard Deviation 16.8
|
16.6 cells per microliter (cells/µL)
Standard Deviation 17.2
|
22.3 cells per microliter (cells/µL)
Standard Deviation 27.1
|
1.8 cells per microliter (cells/µL)
Standard Deviation 8.4
|
17.3 cells per microliter (cells/µL)
Standard Deviation 16.5
|
-1.3 cells per microliter (cells/µL)
Standard Deviation 10.7
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory Wk 12
|
4.9 cells per microliter (cells/µL)
Standard Deviation 15.2
|
24.2 cells per microliter (cells/µL)
Standard Deviation 49.7
|
18.7 cells per microliter (cells/µL)
Standard Deviation 21.9
|
14.8 cells per microliter (cells/µL)
Standard Deviation 15.2
|
-0.6 cells per microliter (cells/µL)
Standard Deviation 11.8
|
8.6 cells per microliter (cells/µL)
Standard Deviation 21.5
|
-0.4 cells per microliter (cells/µL)
Standard Deviation 12.0
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory Wk 24 (n=23,24,25,26,23,23,24)
|
2.2 cells per microliter (cells/µL)
Standard Deviation 19.7
|
15.6 cells per microliter (cells/µL)
Standard Deviation 34.5
|
17.3 cells per microliter (cells/µL)
Standard Deviation 24.5
|
15.3 cells per microliter (cells/µL)
Standard Deviation 17.4
|
3.0 cells per microliter (cells/µL)
Standard Deviation 20.4
|
10.4 cells per microliter (cells/µL)
Standard Deviation 35.6
|
2.5 cells per microliter (cells/µL)
Standard Deviation 14.8
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory, Wk 36
|
1.5 cells per microliter (cells/µL)
Standard Deviation 38.0
|
-9.0 cells per microliter (cells/µL)
Standard Deviation 24.6
|
-8.5 cells per microliter (cells/µL)
Standard Deviation 11.0
|
9.6 cells per microliter (cells/µL)
Standard Deviation 36.5
|
-1.2 cells per microliter (cells/µL)
Standard Deviation 18.2
|
-15.1 cells per microliter (cells/µL)
Standard Deviation 28.7
|
-1.0 cells per microliter (cells/µL)
Standard Deviation 13.4
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
Non-Switched Memory, Wk 48
|
22.9 cells per microliter (cells/µL)
Standard Deviation 88.4
|
-4.4 cells per microliter (cells/µL)
Standard Deviation 32.3
|
-13.3 cells per microliter (cells/µL)
Standard Deviation 9.3
|
-7.4 cells per microliter (cells/µL)
Standard Deviation 38.5
|
-3.0 cells per microliter (cells/µL)
Standard Deviation 17.7
|
-17.3 cells per microliter (cells/µL)
Standard Deviation 19.9
|
-5.8 cells per microliter (cells/µL)
Standard Deviation 16.7
|
Adverse Events
4 mg LY2127399 Q4W, Treatment
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
12 mg LY2127399 Q4W, Treatment
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
40 mg LY2127399 Q4W, Treatment
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
120 mg LY2127399 Q4W, Treatment
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
4 mg LY2127399 Q12W, Treatment
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
120 mg LY2127399 Q12W, Treatment
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo, Treatment
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
4 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
12 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
40 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
120 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
4 mg LY2127399 Q12W, Post-Study Treatment Follow-Up
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
120 mg LY2127399 Q12W, Post-Study Treatment Follow-Up
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo, Post-Study Treatment Follow-Up
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4 mg LY2127399 Q4W, Treatment
n=35 participants at risk
Adverse Events (AEs) reported during study treatment (up to Week 24).
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W, Treatment
n=34 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W, Treatment
n=34 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W, Treatment
n=36 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W, Treatment
n=36 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W, Treatment
n=35 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection every Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo, Treatment
n=35 participants at risk
AEs reported during study treatment (up to Week 24).
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
n=35 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 4 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
12 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
n=34 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 12 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
40 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
n=34 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 40 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
120 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
n=36 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 120 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
4 mg LY2127399 Q12W, Post-Study Treatment Follow-Up
n=36 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 4 mg LY2127399 subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12) and a placebo subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
No study drug was administered during the post-study treatment follow-up.
|
120 mg LY2127399 Q12W, Post-Study Treatment Follow-Up
n=35 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a120 mg LY2127399 subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12) and a placebo subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
No study drug was administered during the post-study treatment follow-up.
|
Placebo, Post-Study Treatment Follow-Up
n=35 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a placebo subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Congenital, familial and genetic disorders
HEART DISEASE CONGENITAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
CHEST PAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER IN SITU
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
AXONAL NEUROPATHY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS RELAPSE
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.8%
3/34 • Number of events 4 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.3%
3/36 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
PARESIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
Other adverse events
| Measure |
4 mg LY2127399 Q4W, Treatment
n=35 participants at risk
Adverse Events (AEs) reported during study treatment (up to Week 24).
LY2127399: 4 mg subcutaneous injection Q4W for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
12 mg LY2127399 Q4W, Treatment
n=34 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 12 mg subcutaneous injection Q4W for 24 weeks.
|
40 mg LY2127399 Q4W, Treatment
n=34 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 40 mg subcutaneous injection Q4W for 24 weeks.
|
120 mg LY2127399 Q4W, Treatment
n=36 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 120 mg subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q12W, Treatment
n=36 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 4 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
|
120 mg LY2127399 Q12W, Treatment
n=35 participants at risk
AEs reported during study treatment (up to Week 24).
LY2127399: 120 mg subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12).
Placebo: Subcutaneous injection every Q4W for 24 weeks (except Weeks 0 and 12).
|
Placebo, Treatment
n=35 participants at risk
AEs reported during study treatment (up to Week 24).
Placebo: Subcutaneous injection Q4W for 24 weeks.
|
4 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
n=35 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 4 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
12 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
n=34 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 12 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
40 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
n=34 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 40 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
120 mg LY2127399 Q4W, Post-Study Treatment Follow-Up
n=36 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 120 mg LY2127399 subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
4 mg LY2127399 Q12W, Post-Study Treatment Follow-Up
n=36 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a 4 mg LY2127399 subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12) and a placebo subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
No study drug was administered during the post-study treatment follow-up.
|
120 mg LY2127399 Q12W, Post-Study Treatment Follow-Up
n=35 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a120 mg LY2127399 subcutaneous injection Q12W for 24 weeks (Weeks 0 and 12) and a placebo subcutaneous injection Q4W for 24 weeks (except Weeks 0 and 12).
No study drug was administered during the post-study treatment follow-up.
|
Placebo, Post-Study Treatment Follow-Up
n=35 participants at risk
AEs that started or worsened after Week 24 or ED through long-term follow-up (up to Week 108) for participants who received a placebo subcutaneous injection Q4W for 24 weeks.
No study drug was administered during the post-study treatment follow-up.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATION ABNORMAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
RADICULOPATHY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
SENSORY DISTURBANCE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
SENSORY LOSS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
AFFECT LABILITY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
IRRITABILITY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
VIRAL RHINITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
NYSTAGMUS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
OPTIC NEURITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
MALAISE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK LEFT
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Cardiac disorders
LEFT VENTRICULAR HYPERTROPHY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
EUSTACHIAN TUBE DYSFUNCTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
EUSTACHIAN TUBE OBSTRUCTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
TINNITUS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Endocrine disorders
GOITRE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
DIPLOPIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
DRY EYE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
EYE ALLERGY
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
EYE MOVEMENT DISORDER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
OPTIC NERVE DISORDER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
UVEITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.6%
3/35 • Number of events 4 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
DRY MOUTH
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
GASTROINTESTINAL MOTILITY DISORDER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
11.4%
4/35 • Number of events 6 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.8%
3/34 • Number of events 5 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
ASTHENIA
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
CHEST PAIN
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
CHILLS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
CYST
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
ENERGY INCREASED
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
PARAESTHESIA
|
5.7%
2/35 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
FACIAL PAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
FATIGUE
|
11.4%
4/35 • Number of events 4 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
11.8%
4/34 • Number of events 4 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.8%
3/34 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
FEELING COLD
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
FEELING HOT
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
GAIT DISTURBANCE
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
HYPERPYREXIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
INJECTION SITE HAEMATOMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
INJECTION SITE OEDEMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
INJECTION SITE PAIN
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
11.8%
4/34 • Number of events 8 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.8%
3/34 • Number of events 8 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
11.1%
4/36 • Number of events 8 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 6 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
OEDEMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
PAIN
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
PYREXIA
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
SENSATION OF FOREIGN BODY
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
General disorders
TEMPERATURE INTOLERANCE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
CERVICITIS
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.8%
1/21 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
CYSTITIS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
DERMATITIS INFECTED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
EYE INFECTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
GASTROENTERITIS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
HEPATITIS B
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
HERPES SIMPLEX
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.6%
3/35 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.3%
3/36 • Number of events 5 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.6%
3/35 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
RHINOTRACHEITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
SINUSITIS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
14.7%
5/34 • Number of events 5 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.8%
3/34 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.6%
3/35 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.6%
3/35 • Number of events 4 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
11.8%
4/34 • Number of events 5 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.8%
1/21 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
VAGINITIS BACTERIAL
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.8%
1/21 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Infections and infestations
VIRAL INFECTION
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
ALLERGIC TRANSFUSION REACTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 5 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
2.9%
1/35 • Number of events 6 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 11 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
PUBIS FRACTURE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
AMYLASE INCREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
CREATININE RENAL CLEARANCE DECREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
ELECTROCARDIOGRAM ABNORMAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
ELECTROCARDIOGRAM QT INTERVAL ABNORMAL
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
HAEMOGLOBIN A PRESENT
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
HEPATITIS B CORE ANTIBODY POSITIVE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
HEPATITIS B SURFACE ANTIBODY POSITIVE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
LIPASE INCREASED
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Investigations
URINE LEUKOCYTE ESTERASE POSITIVE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
OBESITY
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 4 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TWITCHING
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
PERIARTHRITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
SENSATION OF HEAVINESS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN UTERINE NEOPLASM
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.8%
1/21 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
AREFLEXIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
BALANCE DISORDER
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
BURNING SENSATION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
DROOLING
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
DYSKINESIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
FACIAL SPASM
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
HEAD DISCOMFORT
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
HEADACHE
|
14.3%
5/35 • Number of events 12 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.8%
3/34 • Number of events 5 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
11.8%
4/34 • Number of events 5 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.3%
3/36 • Number of events 4 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
14.3%
5/35 • Number of events 6 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.6%
3/35 • Number of events 9 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
HYPOAESTHESIA
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 4 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
MONOPARESIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS RELAPSE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
NEURALGIA
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
ANXIETY
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.3%
3/36 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
CLAUSTROPHOBIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
DEPRESSION
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
8.8%
3/34 • Number of events 5 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 3 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.9%
2/34 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
5.6%
2/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
NERVOUSNESS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
PANIC ATTACK
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
BLADDER IRRITATION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
INCONTINENCE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
NEUROGENIC BLADDER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
URETHRAL POLYP
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Renal and urinary disorders
URINE FLOW DECREASED
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
ATROPHIC VULVOVAGINITIS
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.8%
1/21 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
EPIDIDYMITIS
|
0.00%
0/11 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/12 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/7 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/9 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/11 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/11 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/11 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/12 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/7 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/15 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/9 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/11 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/11 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
MENSTRUATION DELAYED
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
MENSTRUATION IRREGULAR
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
OVARIAN ADHESION
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.8%
1/21 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
3.7%
1/27 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Reproductive system and breast disorders
VULVOVAGINAL DISCOMFORT
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
4.8%
1/21 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/22 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/21 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/27 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/24 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.7%
2/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
8.6%
3/35 • Number of events 9 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT TIGHTNESS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
HAIR TEXTURE ABNORMAL
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
LICHEN PLANUS
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
SCAR
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
SKIN SWELLING
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.8%
1/36 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/34 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
2.9%
1/35 • Number of events 1 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
|
Vascular disorders
VENOUS STENOSIS
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/34 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/36 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
2.9%
1/35 • Number of events 2 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
0.00%
0/35 • Baseline through end of study treatment (up to and through Week 24 or ED) and post-study treatment follow-up (start of Week 25 or ED) through study completion (up to and through Week 48) plus long-term follow-up (up to and through Week 108)
Randomized participants who received any amount of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60