Trial Outcomes & Findings for A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (NCT NCT05872620)
NCT ID: NCT05872620
Last Updated: 2026-09-04
Results Overview
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral antihyperglycemic medications (AHMs) classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1613 participants
Primary outcome timeframe
Baseline, Week 72
Results posted on
2026-09-04
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 milligram (mg) equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
630
|
329
|
332
|
322
|
|
Overall Study
Received At Least One Dose of Study Drug
|
628
|
328
|
331
|
321
|
|
Overall Study
COMPLETED
|
552
|
287
|
303
|
302
|
|
Overall Study
NOT COMPLETED
|
78
|
42
|
29
|
20
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 milligram (mg) equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
7
|
6
|
3
|
|
Overall Study
Death
|
4
|
0
|
4
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
8
|
10
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
38
|
20
|
10
|
10
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
17
|
4
|
5
|
2
|
Baseline Characteristics
A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
Total
n=1613 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 10.9 • n=23 Participants
|
56.8 years
STANDARD_DEVIATION 10.4 • n=23 Participants
|
56.2 years
STANDARD_DEVIATION 10.5 • n=22 Participants
|
58.1 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
56.8 years
STANDARD_DEVIATION 10.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
298 Participants
n=23 Participants
|
150 Participants
n=23 Participants
|
155 Participants
n=22 Participants
|
154 Participants
n=21 Participants
|
757 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
332 Participants
n=23 Participants
|
179 Participants
n=23 Participants
|
177 Participants
n=22 Participants
|
168 Participants
n=21 Participants
|
856 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
194 Participants
n=23 Participants
|
102 Participants
n=23 Participants
|
95 Participants
n=22 Participants
|
97 Participants
n=21 Participants
|
488 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
416 Participants
n=23 Participants
|
221 Participants
n=23 Participants
|
229 Participants
n=22 Participants
|
218 Participants
n=21 Participants
|
1084 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=23 Participants
|
6 Participants
n=23 Participants
|
8 Participants
n=22 Participants
|
7 Participants
n=21 Participants
|
41 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
112 Participants
n=23 Participants
|
58 Participants
n=23 Participants
|
55 Participants
n=22 Participants
|
54 Participants
n=21 Participants
|
279 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=23 Participants
|
21 Participants
n=23 Participants
|
19 Participants
n=22 Participants
|
28 Participants
n=21 Participants
|
105 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
442 Participants
n=23 Participants
|
238 Participants
n=23 Participants
|
235 Participants
n=22 Participants
|
228 Participants
n=21 Participants
|
1143 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=23 Participants
|
5 Participants
n=23 Participants
|
12 Participants
n=22 Participants
|
6 Participants
n=21 Participants
|
45 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=23 Participants
|
5 Participants
n=23 Participants
|
8 Participants
n=22 Participants
|
5 Participants
n=21 Participants
|
30 Participants
n=24 Participants
|
|
Region of Enrollment
Argentina
|
59 Participants
n=23 Participants
|
31 Participants
n=23 Participants
|
31 Participants
n=22 Participants
|
28 Participants
n=21 Participants
|
149 Participants
n=24 Participants
|
|
Region of Enrollment
Australia
|
35 Participants
n=23 Participants
|
18 Participants
n=23 Participants
|
19 Participants
n=22 Participants
|
20 Participants
n=21 Participants
|
92 Participants
n=24 Participants
|
|
Region of Enrollment
Brazil
|
91 Participants
n=23 Participants
|
46 Participants
n=23 Participants
|
49 Participants
n=22 Participants
|
48 Participants
n=21 Participants
|
234 Participants
n=24 Participants
|
|
Region of Enrollment
China
|
47 Participants
n=23 Participants
|
22 Participants
n=23 Participants
|
21 Participants
n=22 Participants
|
23 Participants
n=21 Participants
|
113 Participants
n=24 Participants
|
|
Region of Enrollment
Czechia
|
74 Participants
n=23 Participants
|
40 Participants
n=23 Participants
|
42 Participants
n=22 Participants
|
38 Participants
n=21 Participants
|
194 Participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
67 Participants
n=23 Participants
|
34 Participants
n=23 Participants
|
35 Participants
n=22 Participants
|
34 Participants
n=21 Participants
|
170 Participants
n=24 Participants
|
|
Region of Enrollment
Greece
|
29 Participants
n=23 Participants
|
18 Participants
n=23 Participants
|
16 Participants
n=22 Participants
|
15 Participants
n=21 Participants
|
78 Participants
n=24 Participants
|
|
Region of Enrollment
India
|
35 Participants
n=23 Participants
|
18 Participants
n=23 Participants
|
18 Participants
n=22 Participants
|
18 Participants
n=21 Participants
|
89 Participants
n=24 Participants
|
|
Region of Enrollment
South Korea
|
20 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
11 Participants
n=22 Participants
|
9 Participants
n=21 Participants
|
52 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
173 Participants
n=23 Participants
|
90 Participants
n=23 Participants
|
90 Participants
n=22 Participants
|
89 Participants
n=21 Participants
|
442 Participants
n=24 Participants
|
|
Baseline Weight
|
101.19 kilogram (kg)
STANDARD_DEVIATION 22.62 • n=23 Participants
|
102.29 kilogram (kg)
STANDARD_DEVIATION 22.74 • n=23 Participants
|
102.71 kilogram (kg)
STANDARD_DEVIATION 21.32 • n=22 Participants
|
99.78 kilogram (kg)
STANDARD_DEVIATION 22.99 • n=21 Participants
|
101.45 kilogram (kg)
STANDARD_DEVIATION 22.46 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis.
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral antihyperglycemic medications (AHMs) classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight
|
-2.21 percent change
Standard Error 0.215
|
-5.50 percent change
Standard Error 0.356
|
-7.78 percent change
Standard Error 0.411
|
-10.54 percent change
Standard Error 0.466
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
|
24.4 Percentage of participants
|
49.8 Percentage of participants
|
60.2 Percentage of participants
|
72.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.
Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline
|
7.0 Percentage of participants
|
23.9 Percentage of participants
|
35.5 Percentage of participants
|
50.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.
Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline
|
1.9 Percentage of participants
|
7.3 Percentage of participants
|
17.7 Percentage of participants
|
28.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis.
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Change From Baseline in Waist Circumference
|
-2.67 centimeters
Standard Error 0.233
|
-5.64 centimeters
Standard Error 0.394
|
-7.16 centimeters
Standard Error 0.422
|
-9.16 centimeters
Standard Error 0.437
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis.
* Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time. * Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) %
|
-0.14 percentage of HbA1c
Standard Error 0.060
|
-1.29 percentage of HbA1c
Standard Error 0.069
|
-1.60 percentage of HbA1c
Standard Error 0.058
|
-1.79 percentage of HbA1c
Standard Error 0.059
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis.
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose (FSG)
|
1.2 milligram per deciliter (mg/dL)
Standard Error 1.90
|
-33.0 milligram per deciliter (mg/dL)
Standard Error 2.13
|
-41.1 milligram per deciliter (mg/dL)
Standard Error 1.69
|
-45.8 milligram per deciliter (mg/dL)
Standard Error 1.79
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.
Percentage of participants who achieved hemoglobin A1c (HbA1c\<6.5%) was analysed by Logistic regression with the following variables: region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<6.5%)
|
10.6 Percentage of participants
|
56.2 Percentage of participants
|
67.5 Percentage of participants
|
75.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis. Missing values were imputed using multiple imputation and combined using Rubin's rules.
Percentage of participants who achieved hemoglobin A1c (HbA1c\<7%) was analysed by Logistic regression with the following variables: region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=329 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=332 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=322 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<7.0%)
|
23.0 Percentage of participants
|
70.0 Percentage of participants
|
78.0 Percentage of participants
|
85.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=983 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
|
-1.48 millimeters of mercury (mmHg)
Standard Error 0.534
|
-4.90 millimeters of mercury (mmHg)
Standard Error 0.414
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.
Values represented under Least Squares (LS) Mean are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with region + Baseline\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=630 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=983 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
|
-1.39 millimeters of mercury (mmHg)
Standard Error 0.323
|
-1.32 millimeters of mercury (mmHg)
Standard Error 0.261
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments or glycemic rescue therapy were included in the analysis.
* Fasting Insulin is a test used to measure the amount of insulin in the body. * Values represented under "Geometric Least Squares Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.
Outcome measures
| Measure |
Placebo
n=609 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=321 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=321 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=313 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Insulin
|
-8.8 percent change
Standard Error 2.54
|
-6.4 percent change
Standard Error 2.89
|
-8.3 percent change
Standard Error 3.18
|
-18.0 percent change
Standard Error 2.91
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.
Values represented under "Geometric Least Squares Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.
Outcome measures
| Measure |
Placebo
n=607 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=952 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
|
-2.95 percent change
Standard Error 1.182
|
-6.41 percent change
Standard Error 0.880
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.
Values represented under "Geometric Least Square Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)\*Time\*Treatment + Strata\*Time\*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.
Outcome measures
| Measure |
Placebo
n=607 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=949 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
|
-4.70 percent change
Standard Error 1.688
|
-17.59 percent change
Standard Error 1.096
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. All data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments were included in this analysis. As pre-specified in the Statistical Analysis Plan (SAP), this outcome was analyzed using pooled data from the 6 mg, 12 mg, and 36 mg orforglipron dose groups.
The SF-36v2 acute form, (1-week recall version) assesses participants' health-related quality of life on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
Outcome measures
| Measure |
Placebo
n=629 Participants
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=983 Participants
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
Physical Component Score
|
0.42 T-score
Standard Error 0.271
|
1.47 T-score
Standard Error 0.219
|
—
|
—
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
Mental Component Score
|
-0.50 T-score
Standard Error 0.270
|
-0.10 T-score
Standard Error 0.215
|
—
|
—
|
Adverse Events
Placebo
Serious events: 55 serious events
Other events: 452 other events
Deaths: 4 deaths
6 mg Orforglipron QD
Serious events: 24 serious events
Other events: 231 other events
Deaths: 0 deaths
12 mg Orforglipron QD
Serious events: 34 serious events
Other events: 262 other events
Deaths: 4 deaths
36 mg Orforglipron QD
Serious events: 35 serious events
Other events: 255 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=628 participants at risk
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=328 participants at risk
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=331 participants at risk
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=321 participants at risk
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.48%
3/628 • Number of events 3 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
2/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.91%
3/328 • Number of events 3 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrial flutter
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.48%
3/628 • Number of events 3 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.62%
2/321 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.62%
2/321 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/332 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.56%
1/179 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/177 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/168 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Strabismus
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.16%
1/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Complication associated with device
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Cyst
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Death
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Impaired healing
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
2/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Perirectal abscess
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gangrene
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Klebsiella infection
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Perineal abscess
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Peritonitis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
2/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 3 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.91%
3/331 • Number of events 3 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Euglycaemic diabetic ketoacidosis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.32%
2/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.61%
2/328 • Number of events 3 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.32%
2/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal adenocarcinoma
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine fibroma
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.32%
2/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract neoplasm
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.34%
1/296 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/149 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/154 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/153 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Occipital lobe stroke
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Piriformis syndrome
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.32%
2/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Product Issues
Device malfunction
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.62%
2/321 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal colic
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Aortic aneurysm
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Aortic stenosis
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/328 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/628 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.32%
2/628 • Number of events 2 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.31%
1/321 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Peripheral ischaemia
|
0.16%
1/628 • Number of events 1 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/328 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/331 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/321 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=628 participants at risk
Participants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
|
6 mg Orforglipron QD
n=328 participants at risk
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
|
12 mg Orforglipron QD
n=331 participants at risk
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
|
36 mg Orforglipron QD
n=321 participants at risk
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
|
|---|---|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
5.4%
34/628 • Number of events 41 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.6%
15/328 • Number of events 16 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
14/331 • Number of events 16 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
17/321 • Number of events 20 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.5%
22/628 • Number of events 26 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.0%
23/328 • Number of events 39 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
23/331 • Number of events 29 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.4%
27/321 • Number of events 40 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
16/628 • Number of events 18 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
19/328 • Number of events 25 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.0%
20/331 • Number of events 30 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
17/321 • Number of events 28 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
17/628 • Number of events 19 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.5%
18/328 • Number of events 36 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.3%
21/331 • Number of events 27 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
12/321 • Number of events 14 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
7.8%
49/628 • Number of events 59 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.7%
58/328 • Number of events 71 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.1%
70/331 • Number of events 87 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
22.4%
72/321 • Number of events 99 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
94/628 • Number of events 141 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.3%
70/328 • Number of events 118 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
24.8%
82/331 • Number of events 168 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
27.4%
88/321 • Number of events 153 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
22/628 • Number of events 27 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
30/328 • Number of events 44 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
51/331 • Number of events 59 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.9%
35/321 • Number of events 48 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.64%
4/628 • Number of events 4 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
21/328 • Number of events 25 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.5%
38/331 • Number of events 58 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
28/321 • Number of events 38 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
17/628 • Number of events 17 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.3%
24/328 • Number of events 29 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
23/331 • Number of events 27 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
23/321 • Number of events 32 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
18/628 • Number of events 24 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
19/328 • Number of events 20 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
23/331 • Number of events 25 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
22/321 • Number of events 32 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
8.4%
53/628 • Number of events 64 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.1%
66/328 • Number of events 94 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
31.1%
103/331 • Number of events 177 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
36.4%
117/321 • Number of events 215 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
24/628 • Number of events 28 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.8%
42/328 • Number of events 60 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.2%
67/331 • Number of events 147 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
74/321 • Number of events 164 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
2.9%
18/628 • Number of events 21 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.0%
10/328 • Number of events 12 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.0%
20/331 • Number of events 22 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
17/321 • Number of events 19 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
6.4%
40/628 • Number of events 41 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
11/328 • Number of events 13 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.4%
18/331 • Number of events 19 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
18/321 • Number of events 18 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
4.8%
30/628 • Number of events 33 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.9%
16/328 • Number of events 17 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
17/331 • Number of events 20 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
10/321 • Number of events 10 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
59/628 • Number of events 85 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
30/328 • Number of events 41 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.6%
22/331 • Number of events 35 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
23/321 • Number of events 28 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
55/628 • Number of events 83 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.6%
25/328 • Number of events 32 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.7%
32/331 • Number of events 41 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
33/321 • Number of events 37 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
24/628 • Number of events 27 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.0%
13/328 • Number of events 14 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.4%
18/331 • Number of events 27 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
16/321 • Number of events 20 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
3.3%
21/628 • Number of events 24 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.4%
8/328 • Number of events 8 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
12/331 • Number of events 12 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
18/321 • Number of events 19 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
18/628 • Number of events 18 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
27/328 • Number of events 36 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
30/331 • Number of events 33 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.3%
49/321 • Number of events 55 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
39.3%
247/628 • Number of events 276 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.1%
43/328 • Number of events 44 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.7%
32/331 • Number of events 36 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.4%
27/321 • Number of events 29 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
32/628 • Number of events 37 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
17/328 • Number of events 18 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
14/331 • Number of events 15 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.7%
15/321 • Number of events 15 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
27/628 • Number of events 30 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.5%
18/328 • Number of events 18 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
13/331 • Number of events 13 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
21/321 • Number of events 26 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
2.9%
18/628 • Number of events 21 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
19/328 • Number of events 22 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.3%
11/331 • Number of events 16 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
22/321 • Number of events 32 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
5.3%
33/628 • Number of events 44 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
17/328 • Number of events 20 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
19/331 • Number of events 32 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
22/321 • Number of events 39 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
6.2%
39/628 • Number of events 46 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
14/328 • Number of events 16 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
19/331 • Number of events 22 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
16/321 • Number of events 18 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60