Trial Outcomes & Findings for A Study of LY3437943 in Participants Who Have Obesity or Are Overweight (NCT NCT04881760)
NCT ID: NCT04881760
Last Updated: 2023-09-13
Results Overview
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
338 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2023-09-13
Participant Flow
Four maintenance doses of LY3437943 were evaluated in the trial: 1, 4, 8, and 12 milligrams (mg). Dose escalation to improve gastrointestinal (GI) tolerability occured in certain treatment groups up to Week 12 by increasing the volume of administered study drug (or placebo) during the 48-week double-blind, placebo-controlled treatment period.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
|
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
33
|
34
|
35
|
35
|
62
|
|
Overall Study
Received at Least One Dose of Study Drug
|
70
|
69
|
33
|
33
|
35
|
35
|
62
|
|
Overall Study
COMPLETED
|
50
|
60
|
26
|
26
|
30
|
29
|
54
|
|
Overall Study
NOT COMPLETED
|
20
|
9
|
7
|
8
|
5
|
6
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
|
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
1
|
1
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
5
|
1
|
2
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
13
|
1
|
1
|
4
|
2
|
1
|
2
|
|
Overall Study
Randomized but Never Treated
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Inadvertent Enrollment
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Site Closure
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
Baseline characteristics by cohort
| Measure |
Placebo
n=70 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=34 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY343794 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.00 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
50.60 years
STANDARD_DEVIATION 13.30 • n=7 Participants
|
50.80 years
STANDARD_DEVIATION 11.88 • n=5 Participants
|
46.80 years
STANDARD_DEVIATION 14.10 • n=4 Participants
|
46.10 years
STANDARD_DEVIATION 13.52 • n=21 Participants
|
48.70 years
STANDARD_DEVIATION 11.14 • n=10 Participants
|
45.80 years
STANDARD_DEVIATION 12.18 • n=115 Participants
|
48.20 years
STANDARD_DEVIATION 12.73 • n=24 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
163 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
175 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
117 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
220 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 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
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
27 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
298 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
69 participants
n=7 Participants
|
33 participants
n=5 Participants
|
34 participants
n=4 Participants
|
35 participants
n=21 Participants
|
35 participants
n=10 Participants
|
62 participants
n=115 Participants
|
338 participants
n=24 Participants
|
|
Baseline Body Weight
|
109.21 kilograms (kg)
STANDARD_DEVIATION 20.88 • n=5 Participants
|
106.36 kilograms (kg)
STANDARD_DEVIATION 19.84 • n=7 Participants
|
108.04 kilograms (kg)
STANDARD_DEVIATION 26.31 • n=5 Participants
|
107.01 kilograms (kg)
STANDARD_DEVIATION 21.29 • n=4 Participants
|
106.50 kilograms (kg)
STANDARD_DEVIATION 21.55 • n=21 Participants
|
108.63 kilograms (kg)
STANDARD_DEVIATION 20.88 • n=10 Participants
|
107.97 kilograms (kg)
STANDARD_DEVIATION 21.69 • n=115 Participants
|
107.73 kilograms (kg)
STANDARD_DEVIATION 21.35 • n=24 Participants
|
|
Baseline Body Mass Index (BMI)
|
37.31 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 5.90 • n=5 Participants
|
37.49 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 5.85 • n=7 Participants
|
37.27 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 5.87 • n=5 Participants
|
37.39 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.66 • n=4 Participants
|
37.37 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 6.04 • n=21 Participants
|
36.96 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 5.49 • n=10 Participants
|
37.42 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 5.98 • n=115 Participants
|
37.34 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 5.71 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who had baseline and at least one post-baseline body weight value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in Body Weight
|
-1.55 percent change
Standard Error 0.54
|
-7.18 percent change
Standard Error 0.67
|
-12.00 percent change
Standard Error 0.71
|
-13.80 percent change
Standard Error 0.97
|
-16.64 percent change
Standard Error 0.74
|
-18.26 percent change
Standard Error 0.95
|
-17.39 percent change
Standard Error 0.69
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: All randomized participants who had baseline and at least one post-baseline body weight value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Mean Percent Change From Baseline in Body Weight
|
-2.11 percent change
Standard Error 0.73
|
-8.67 percent change
Standard Error 0.95
|
-16.32 percent change
Standard Error 1.58
|
-17.83 percent change
Standard Error 1.53
|
-21.72 percent change
Standard Error 1.41
|
-23.88 percent change
Standard Error 1.51
|
-24.22 percent change
Standard Error 1.24
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants who had baseline and at least one post-baseline value for ≥ 5% body weight reduction excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kilograms per square meter (kg/m2), ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
|
26 percentage of participants
|
59 percentage of participants
|
87 percentage of participants
|
94 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
97 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: All randomized participants who had baseline and at least one post-baseline value for ≥ 5% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
|
27 percentage of participants
|
64 percentage of participants
|
87 percentage of participants
|
97 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants who had baseline and at least one post-baseline value for ≥ 10% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
|
3 percentage of participants
|
25 percentage of participants
|
59 percentage of participants
|
72 percentage of participants
|
83 percentage of participants
|
94 percentage of participants
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: All randomized participants who had baseline and at least one post-baseline value for ≥ 10% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
|
9 percentage of participants
|
27 percentage of participants
|
73 percentage of participants
|
76 percentage of participants
|
90 percentage of participants
|
91 percentage of participants
|
93 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants who had baseline and at least one post-baseline value for ≥ 15% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
|
1 percentage of participants
|
10 percentage of participants
|
29 percentage of participants
|
44 percentage of participants
|
51 percentage of participants
|
68 percentage of participants
|
70 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: All randomized participants who had baseline and at least one post-baseline value for ≥ 15% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
|
2 percentage of participants
|
16 percentage of participants
|
55 percentage of participants
|
64 percentage of participants
|
73 percentage of participants
|
77 percentage of participants
|
83 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who had baseline and at least one post-baseline value for body weight, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight
|
-1.27 kilograms (kg)
Standard Error 0.63
|
-7.72 kilograms (kg)
Standard Error 0.73
|
-12.59 kilograms (kg)
Standard Error 0.81
|
-14.79 kilograms (kg)
Standard Error 1.09
|
-17.70 kilograms (kg)
Standard Error 0.79
|
-19.75 kilograms (kg)
Standard Error 1.08
|
-18.53 kilograms (kg)
Standard Error 0.71
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: All randomized participants who had baseline and at least one post-baseline value for body weight, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight
|
-1.84 kg
Standard Error 0.83
|
-9.37 kg
Standard Error 1.06
|
-17.32 kg
Standard Error 1.78
|
-19.13 kg
Standard Error 1.80
|
-23.52 kg
Standard Error 1.61
|
-25.88 kg
Standard Error 1.68
|
-26.17 kg
Standard Error 1.33
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who had baseline and at least one post-baseline BMI value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in BMI
|
-0.49 kg/m^2
Standard Error 0.21
|
-2.64 kg/m^2
Standard Error 0.26
|
-4.47 kg/m^2
Standard Error 0.28
|
-5.13 kg/m^2
Standard Error 0.36
|
-6.15 kg/m^2
Standard Error 0.27
|
-6.84 kg/m^2
Standard Error 0.36
|
-6.44 kg/m^2
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: All randomized participants who had baseline and at least one post-baseline BMI value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in BMI
|
-0.72 kg/m^2
Standard Error 0.29
|
-3.22 kg/m^2
Standard Error 0.37
|
-6.14 kg/m^2
Standard Error 0.65
|
-6.67 kg/m^2
Standard Error 0.59
|
-8.12 kg/m^2
Standard Error 0.55
|
-9.02 kg/m^2
Standard Error 0.57
|
-9.14 kg/m^2
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who had baseline and at least one post-baseline waist circumference value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=32 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Waist Circumference
|
-2.60 centimeters (cm)
Standard Error 0.80
|
-5.43 centimeters (cm)
Standard Error 0.94
|
-10.33 centimeters (cm)
Standard Error 1.05
|
-12.55 centimeters (cm)
Standard Error 1.00
|
-13.74 centimeters (cm)
Standard Error 1.04
|
-14.99 centimeters (cm)
Standard Error 0.98
|
-14.33 centimeters (cm)
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: All randomized participants who had baseline and at least one post-baseline waist circumference value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 Participants
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=32 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 Participants
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 Participants
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 Participants
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Waist Circumference
|
-2.64 cm
Standard Error 0.99
|
-6.49 cm
Standard Error 1.12
|
-14.58 cm
Standard Error 1.56
|
-14.87 cm
Standard Error 1.73
|
-18.53 cm
Standard Error 1.46
|
-18.50 cm
Standard Error 1.52
|
-19.60 cm
Standard Error 1.29
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
1 mg LY3437943
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
4 mg LY3437943 (2 mg)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
4 mg LY3437943
Serious events: 2 serious events
Other events: 24 other events
Deaths: 1 deaths
8 mg LY3437943 (2 mg)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
8 mg LY3437943 (4 mg)
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
12 mg LY3437943 (2 mg)
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=70 participants at risk
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 participants at risk
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 participants at risk
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 participants at risk
Participants received 2 mg LY343794 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 participants at risk
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.4%
1/70 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.6%
1/62 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
General disorders
Chest discomfort
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.4%
1/69 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
General disorders
Drowning
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Infections and infestations
Covid-19
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
1.4%
1/70 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Investigations
Blood calcitonin increased
|
1.4%
1/70 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.6%
1/62 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
2/69 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
Other adverse events
| Measure |
Placebo
n=70 participants at risk
Participants received placebo matched to LY3437943 administered as SC injection QW.
|
1 mg LY3437943
n=69 participants at risk
Participants received 1 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943 (2 mg)
n=33 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
|
4 mg LY3437943
n=33 participants at risk
Participants received 4 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (2 mg)
n=35 participants at risk
Participants received 2 mg LY343794 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
|
8 mg LY3437943 (4 mg)
n=35 participants at risk
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
|
12 mg LY3437943 (2 mg)
n=62 participants at risk
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
2/70 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
4.3%
3/69 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.6%
3/35 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
4.8%
3/62 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
2/70 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
7.2%
5/69 • Number of events 7 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
15.2%
5/33 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
11.4%
4/35 • Number of events 5 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
11.4%
4/35 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
16.1%
10/62 • Number of events 13 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
8/70 • Number of events 9 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.7%
6/69 • Number of events 8 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
12.1%
4/33 • Number of events 5 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
12.1%
4/33 • Number of events 5 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
20.0%
7/35 • Number of events 11 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
20.0%
7/35 • Number of events 9 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
14.5%
9/62 • Number of events 17 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
2/70 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.4%
1/69 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.1%
5/62 • Number of events 7 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
1/70 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.4%
1/69 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
9.1%
3/33 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.6%
3/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.5%
4/62 • Number of events 8 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
8/70 • Number of events 8 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
14.5%
10/69 • Number of events 12 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
18.2%
6/33 • Number of events 9 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
36.4%
12/33 • Number of events 21 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
17.1%
6/35 • Number of events 9 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
60.0%
21/35 • Number of events 33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
45.2%
28/62 • Number of events 63 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/70 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
2/69 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
12.1%
4/33 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
12.1%
4/33 • Number of events 5 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
25.7%
9/35 • Number of events 9 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
19.4%
12/62 • Number of events 21 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
General disorders
Early satiety
|
5.7%
4/70 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
4.3%
3/69 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
9.7%
6/62 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
General disorders
Fatigue
|
4.3%
3/70 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
4.3%
3/69 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
12.1%
4/33 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.6%
3/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
9.7%
6/62 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Infections and infestations
Covid-19
|
20.0%
14/70 • Number of events 14 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
18.8%
13/69 • Number of events 13 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
12.1%
4/33 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
18.2%
6/33 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
17.1%
6/35 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
31.4%
11/35 • Number of events 11 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
24.2%
15/62 • Number of events 15 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
3/70 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.7%
6/69 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.6%
3/35 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.1%
5/62 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/70 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.4%
1/69 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Infections and infestations
Sinusitis
|
5.7%
4/70 • Number of events 5 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
2/69 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/62 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
2/70 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.8%
4/69 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/70 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
2/69 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/34 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/16 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.7%
1/15 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/17 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/17 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/30 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Investigations
Amylase increased
|
2.9%
2/70 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.9%
2/70 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
7.2%
5/69 • Number of events 5 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.6%
1/62 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Investigations
Lipase increased
|
2.9%
2/70 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
2/69 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
9.1%
3/33 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.1%
5/62 • Number of events 5 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Investigations
Weight decreased
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.4%
1/69 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.6%
1/62 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.6%
6/70 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
13.0%
9/69 • Number of events 10 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
18.2%
6/33 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
24.2%
8/33 • Number of events 8 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
11.4%
4/35 • Number of events 5 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
31.4%
11/35 • Number of events 12 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
29.0%
18/62 • Number of events 19 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Nervous system disorders
Allodynia
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.5%
4/62 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Nervous system disorders
Dizziness
|
2.9%
2/70 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.4%
1/69 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.6%
3/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.1%
5/62 • Number of events 9 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.4%
1/69 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Nervous system disorders
Headache
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
2/69 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
11.4%
4/35 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.5%
4/62 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Nervous system disorders
Hyperaesthesia
|
1.4%
1/70 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.1%
2/33 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/36 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.6%
2/36 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/17 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/18 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/18 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/18 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/32 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.6%
1/62 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
2/69 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/69 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
5.7%
2/35 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.2%
2/62 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Vascular disorders
Hypertension
|
2.9%
2/70 • Number of events 2 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.7%
6/69 • Number of events 6 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
3.0%
1/33 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.6%
3/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/35 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
6.5%
4/62 • Number of events 4 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
|
Vascular disorders
Hypotension
|
0.00%
0/70 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.4%
1/69 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
0.00%
0/33 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
2.9%
1/35 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
8.6%
3/35 • Number of events 3 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
1.6%
1/62 • Number of events 1 • Baseline Through End of Safety Follow-up (Up to 52 Weeks)
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60