Trial Outcomes & Findings for A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (NCT NCT05869903)
NCT ID: NCT05869903
Last Updated: 2026-08-14
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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
3127 participants
Primary outcome timeframe
Baseline, Week 72
Results posted on
2026-08-14
Participant Flow
Results reported here are based on a data cutoff of 30 July 2025, corresponding to completion of the Primary Treatment Period. Final results, including the Additional Treatment Period, will be reported at the time of study completion results posting, no later than October 2028.
This study was designed with two treatment periods. The Primary Treatment Period (Week 0 to Week 72) enrolled participants with normoglycemia or prediabetes at randomization. The Additional Treatment Period (Week 72 to Week 176) is limited to the subset of participants who had prediabetes at randomization and completed the Primary Treatment Period.
Participant milestones
| Measure |
Placebo
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.
|
6 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 milligrams (mg) and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
|
12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
949
|
723
|
725
|
730
|
|
Overall Study
Received at Least One Dose of Study Drug
|
948
|
723
|
724
|
728
|
|
Overall Study
Participants With Normoglycemia at Randomization
|
605
|
465
|
465
|
465
|
|
Overall Study
Participants With Prediabetes at Randomization
|
344
|
258
|
260
|
265
|
|
Overall Study
COMPLETED
|
768
|
625
|
630
|
639
|
|
Overall Study
NOT COMPLETED
|
181
|
98
|
95
|
91
|
Reasons for withdrawal
| Measure |
Placebo
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.
|
6 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 milligrams (mg) and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
|
12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
89
|
38
|
44
|
34
|
|
Overall Study
Lost to Follow-up
|
26
|
14
|
13
|
22
|
|
Overall Study
Adverse Event
|
10
|
8
|
13
|
16
|
|
Overall Study
Site Terminated By Sponsor
|
12
|
15
|
6
|
8
|
|
Overall Study
Protocol Deviation
|
9
|
12
|
10
|
8
|
|
Overall Study
Lack of Efficacy
|
26
|
2
|
1
|
0
|
|
Overall Study
Pregnancy
|
3
|
5
|
6
|
1
|
|
Overall Study
Other - as reported by the investigator
|
2
|
3
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
0
|
1
|
1
|
|
Overall Study
Death
|
1
|
1
|
1
|
0
|
Baseline Characteristics
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
Baseline characteristics by cohort
| Measure |
Placebo
n=949 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
6 mg Orforglipron
n=723 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
|
12 mg Orforglipron
n=725 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
n=730 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
Total
n=3127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 11.9 • n=11 Participants
|
44.9 years
STANDARD_DEVIATION 12.1 • n=11 Participants
|
45.4 years
STANDARD_DEVIATION 12.6 • n=22 Participants
|
44.9 years
STANDARD_DEVIATION 11.9 • n=255 Participants
|
45.1 years
STANDARD_DEVIATION 12.1 • n=83 Participants
|
|
Sex: Female, Male
Female
|
608 Participants
n=11 Participants
|
469 Participants
n=11 Participants
|
467 Participants
n=22 Participants
|
465 Participants
n=255 Participants
|
2009 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
341 Participants
n=11 Participants
|
254 Participants
n=11 Participants
|
258 Participants
n=22 Participants
|
265 Participants
n=255 Participants
|
1118 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
369 Participants
n=11 Participants
|
273 Participants
n=11 Participants
|
275 Participants
n=22 Participants
|
258 Participants
n=255 Participants
|
1175 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
572 Participants
n=11 Participants
|
443 Participants
n=11 Participants
|
441 Participants
n=22 Participants
|
467 Participants
n=255 Participants
|
1923 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
9 Participants
n=22 Participants
|
5 Participants
n=255 Participants
|
29 Participants
n=83 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=11 Participants
|
2 Participants
n=11 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=255 Participants
|
11 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Asian
|
267 Participants
n=11 Participants
|
202 Participants
n=11 Participants
|
201 Participants
n=22 Participants
|
214 Participants
n=255 Participants
|
884 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
3 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Black or African American
|
72 Participants
n=11 Participants
|
68 Participants
n=11 Participants
|
60 Participants
n=22 Participants
|
67 Participants
n=255 Participants
|
267 Participants
n=83 Participants
|
|
Race (NIH/OMB)
White
|
539 Participants
n=11 Participants
|
408 Participants
n=11 Participants
|
405 Participants
n=22 Participants
|
394 Participants
n=255 Participants
|
1746 Participants
n=83 Participants
|
|
Race (NIH/OMB)
More than one race
|
54 Participants
n=11 Participants
|
35 Participants
n=11 Participants
|
45 Participants
n=22 Participants
|
47 Participants
n=255 Participants
|
181 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=11 Participants
|
8 Participants
n=11 Participants
|
10 Participants
n=22 Participants
|
6 Participants
n=255 Participants
|
35 Participants
n=83 Participants
|
|
Region of Enrollment
Brazil
|
273 Participants
n=11 Participants
|
203 Participants
n=11 Participants
|
203 Participants
n=22 Participants
|
205 Participants
n=255 Participants
|
884 Participants
n=83 Participants
|
|
Region of Enrollment
China
|
89 Participants
n=11 Participants
|
69 Participants
n=11 Participants
|
69 Participants
n=22 Participants
|
69 Participants
n=255 Participants
|
296 Participants
n=83 Participants
|
|
Region of Enrollment
India
|
20 Participants
n=11 Participants
|
13 Participants
n=11 Participants
|
13 Participants
n=22 Participants
|
16 Participants
n=255 Participants
|
62 Participants
n=83 Participants
|
|
Region of Enrollment
Japan
|
96 Participants
n=11 Participants
|
75 Participants
n=11 Participants
|
74 Participants
n=22 Participants
|
77 Participants
n=255 Participants
|
322 Participants
n=83 Participants
|
|
Region of Enrollment
Slovakia
|
74 Participants
n=11 Participants
|
56 Participants
n=11 Participants
|
58 Participants
n=22 Participants
|
58 Participants
n=255 Participants
|
246 Participants
n=83 Participants
|
|
Region of Enrollment
South Korea
|
27 Participants
n=11 Participants
|
21 Participants
n=11 Participants
|
20 Participants
n=22 Participants
|
18 Participants
n=255 Participants
|
86 Participants
n=83 Participants
|
|
Region of Enrollment
Spain
|
95 Participants
n=11 Participants
|
69 Participants
n=11 Participants
|
72 Participants
n=22 Participants
|
69 Participants
n=255 Participants
|
305 Participants
n=83 Participants
|
|
Region of Enrollment
Taiwan
|
25 Participants
n=11 Participants
|
17 Participants
n=11 Participants
|
18 Participants
n=22 Participants
|
20 Participants
n=255 Participants
|
80 Participants
n=83 Participants
|
|
Region of Enrollment
United States
|
250 Participants
n=11 Participants
|
200 Participants
n=11 Participants
|
198 Participants
n=22 Participants
|
198 Participants
n=255 Participants
|
846 Participants
n=83 Participants
|
|
Baseline Body Weight
|
103.92 kilograms (kg)
STANDARD_DEVIATION 22.03 • n=11 Participants
|
103.18 kilograms (kg)
STANDARD_DEVIATION 21.65 • n=11 Participants
|
102.18 kilograms (kg)
STANDARD_DEVIATION 21.58 • n=22 Participants
|
103.10 kilograms (kg)
STANDARD_DEVIATION 23.15 • n=255 Participants
|
103.16 kilograms (kg)
STANDARD_DEVIATION 22.11 • n=83 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=949 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=723 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
n=725 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
n=730 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight (Primary Treatment Period)
|
-0.87 percent change
Standard Error 0.247
|
-7.82 percent change
Standard Error 0.302
|
-9.27 percent change
Standard Error 0.335
|
-12.35 percent change
Standard Error 0.364
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 the analysis.
Values represented under "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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=949 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=723 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
n=725 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
n=730 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Change From Baseline in Waist Circumference (Primary Treatment Period)
|
-2.09 centimeters
Standard Error 0.260
|
-7.54 centimeters
Standard Error 0.305
|
-9.00 centimeters
Standard Error 0.318
|
-11.13 centimeters
Standard Error 0.318
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 the 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 "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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=949 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=2178 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
|
-0.78 millimeters of mercury (mmHg)
Standard Error 0.404
|
-6.14 millimeters of mercury (mmHg)
Standard Error 0.283
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 the 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 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 log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=936 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=2146 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
|
-1.41 percent change
Standard Error 0.715
|
-7.57 percent change
Standard Error 0.454
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 the 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 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 log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=936 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=2142 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
|
-4.8 percent change
Standard Error 1.21
|
-16.4 percent change
Standard Error 0.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 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 "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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=948 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=722 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
n=724 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
n=730 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c (Primary Treatment Period)
|
-0.03 percentage of HbA1c
Standard Error 0.010
|
-0.31 percentage of HbA1c
Standard Error 0.010
|
-0.31 percentage of HbA1c
Standard Error 0.010
|
-0.38 percentage of HbA1c
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 the analysis.
Values represented under "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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=949 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=723 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
n=725 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
n=730 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose (FSG) (Primary Treatment Period)
|
0.28 milligram per deciliter (mg/dL)
Standard Error 0.407
|
-7.68 milligram per deciliter (mg/dL)
Standard Error 0.341
|
-8.70 milligram per deciliter (mg/dL)
Standard Error 0.334
|
-9.25 milligram per deciliter (mg/dL)
Standard Error 0.378
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 the analysis.
* Fasting insulin is a blood test that measures the level of insulin in the blood after fasting. * Values represented under "Geometric 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 log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=948 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=723 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
n=724 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
n=730 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Insulin (Primary Treatment Period)
|
-7.30 percent change
Standard Error 2.211
|
-20.64 percent change
Standard Error 1.967
|
-23.87 percent change
Standard Error 2.047
|
-32.78 percent change
Standard Error 1.875
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 the 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 "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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Outcome measures
| Measure |
Placebo
n=949 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=2178 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
|
-0.93 millimeters of mercury (mmHg)
Standard Error 0.273
|
-2.53 millimeters of mercury (mmHg)
Standard Error 0.194
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All randomized participants who had evaluable data for this specific outcome were included. 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 the 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 is a participant-reported measure designed to assess health status using 36 items across 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=949 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
Pooled 6 mg/12 mg/36 mg Orforglipron
n=2175 Participants
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg, 12 mg, or 36 mg, which was then maintained up to week 72. Data from the 6 mg, 12 mg, and 36 mg dose groups were pooled under this arm.
|
12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
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) - Primary Treatment Period
Physical Component Score
|
0.76 T-score
Standard Error 0.232
|
2.28 T-score
Standard Error 0.131
|
—
|
—
|
|
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) - Primary Treatment Period
Mental Component Score
|
-1.08 T-score
Standard Error 0.244
|
-0.65 T-score
Standard Error 0.157
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 176Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 176, Baseline through Week 190Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 46 serious events
Other events: 557 other events
Deaths: 1 deaths
6 mg Orforglipron
Serious events: 40 serious events
Other events: 520 other events
Deaths: 1 deaths
12 mg Orforglipron
Serious events: 39 serious events
Other events: 544 other events
Deaths: 1 deaths
36 mg Orforglipron
Serious events: 28 serious events
Other events: 550 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=948 participants at risk
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
6 mg Orforglipron
n=723 participants at risk
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
|
12 mg Orforglipron
n=724 participants at risk
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
n=728 participants at risk
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Pancytopenia
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Thrombocytopenia
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.21%
2/948 • 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.
|
0.28%
2/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Arrhythmia
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.21%
2/948 • 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.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 acute
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.27%
2/728 • 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
Ventricular tachycardia
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Myocardial bridging
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Retinal vein occlusion
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 hernia
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Chronic gastritis
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Gastritis
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Gastritis haemorrhagic
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Hernial eventration
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 ischaemia
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Large intestine polyp
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.28%
2/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Oesophageal obstruction
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Pancreatitis acute
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.27%
2/728 • 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.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Vomiting
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Systemic inflammatory response syndrome
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Biliary colic
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
|
0.11%
1/948 • 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.
|
0.14%
1/723 • 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.
|
0.14%
1/724 • 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.
|
0.41%
3/728 • 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.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.28%
2/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.11%
1/948 • 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.
|
0.14%
1/723 • 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.
|
0.14%
1/724 • 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.
|
0.27%
2/728 • 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.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Brain abscess
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.28%
2/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Gastroenteritis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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.
|
0.14%
1/724 • 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.
|
0.14%
1/728 • 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
Hepatitis a
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Otitis media
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Pelvic inflammatory disease
|
0.00%
0/607 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.21%
1/466 • 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%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Pharyngitis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Pneumonia bacterial
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Pneumonia legionella
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Pneumonia mycoplasmal
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Pulmonary tuberculosis
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Tonsillitis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Tracheobronchitis
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.11%
1/948 • 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.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Accidental overdose
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Ankle fracture
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Face injury
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Foot fracture
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Hand fracture
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Head injury
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Hip fracture
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Ligament injury
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Ligament rupture
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Ligament sprain
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Nerve root injury lumbar
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Post procedural haemorrhage
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Radius fracture
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Road traffic accident
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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.
|
0.14%
1/728 • 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
Seroma
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Tendon rupture
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Wrist fracture
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Hepatic enzyme increased
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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.
|
|
Investigations
Transaminases increased
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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.
|
|
Investigations
Tumour marker increased
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Arthritis
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.11%
1/948 • 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.
|
0.14%
1/723 • 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.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Jaw cyst
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Nodal osteoarthritis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Scoliosis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 stenosis
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Systemic lupus erythematosus
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Tendon disorder
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 pancreas
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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)
Basal cell carcinoma
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 anorectal neoplasm
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Breast cancer
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Choroid melanoma
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Endometrial adenocarcinoma
|
0.16%
1/607 • 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%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/466 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Invasive ductal breast carcinoma
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Non-hodgkin's lymphoma
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Oesophageal cancer metastatic
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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)
Ovarian cancer metastatic
|
0.00%
0/607 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.21%
1/466 • 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%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.21%
2/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Renal cancer
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Soft tissue sarcoma
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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)
Testicular germ cell tumour mixed
|
0.00%
0/341 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/254 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/258 • 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%
0/264 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.16%
1/607 • 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.
|
0.21%
1/469 • 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%
0/466 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Atypical migraine
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Brain oedema
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Cerebral haemorrhage
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.27%
2/728 • 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.
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Paraesthesia
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Tension headache
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 global amnesia
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Vertebrobasilar artery dissection
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Vith nerve paralysis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/607 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.21%
1/469 • 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%
0/466 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Bipolar disorder
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Depression suicidal
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Bladder perforation
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Calculus urinary
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Glomerulonephritis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.21%
2/948 • 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.
|
0.28%
2/723 • 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.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Nephropathy toxic
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Ureterolithiasis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.41%
3/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Vesicoureteric reflux
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Adenomyosis
|
0.00%
0/607 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/466 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.22%
1/464 • 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.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/607 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.21%
1/466 • 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%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Endometriosis
|
0.00%
0/607 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.21%
1/466 • 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%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Fallopian tube adhesion
|
0.00%
0/607 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/466 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.22%
1/464 • 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.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.16%
1/607 • 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%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/466 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Intermenstrual bleeding
|
0.00%
0/607 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/466 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.22%
1/464 • 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.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.16%
1/607 • 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%
0/469 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/466 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/464 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Acute respiratory failure
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Hypoxia
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Pleurisy
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Pulmonary embolism
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 mass
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/728 • 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
Cellulite
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Psoriasis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Finger amputation
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Arteriosclerosis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Deep vein thrombosis
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.28%
2/724 • 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%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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 urgency
|
0.00%
0/948 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.14%
1/723 • 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%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Varicose vein
|
0.11%
1/948 • 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%
0/723 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/724 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/728 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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=948 participants at risk
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks.
|
6 mg Orforglipron
n=723 participants at risk
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
|
12 mg Orforglipron
n=724 participants at risk
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
|
36 mg Orforglipron
n=728 participants at risk
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
32/948 • 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.
|
7.2%
52/723 • Number of events 62 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.4%
68/724 • 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.
|
8.5%
62/728 • Number of events 69 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
2.6%
25/948 • 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.
|
5.3%
38/723 • Number of events 47 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
50/724 • Number of events 66 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
44/728 • Number of events 53 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
3.5%
33/948 • 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.
|
6.1%
44/723 • Number of events 67 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
45/724 • Number of events 61 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
57/728 • Number of events 81 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
9.3%
88/948 • Number of events 105 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.6%
156/723 • Number of events 202 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
29.8%
216/724 • Number of events 289 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.4%
185/728 • Number of events 231 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
9.6%
91/948 • Number of events 115 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.0%
152/723 • Number of events 235 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
22.8%
165/724 • Number of events 295 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
168/728 • Number of events 272 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
5.0%
47/948 • Number of events 53 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
95/723 • 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.
|
16.2%
117/724 • Number of events 151 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.1%
103/728 • Number of events 142 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
1.1%
10/948 • 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.
|
6.1%
44/723 • 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.
|
5.9%
43/724 • Number of events 57 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
55/728 • 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.
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
17/948 • 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.
|
4.3%
31/723 • 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.
|
5.5%
40/724 • Number of events 52 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
41/728 • Number of events 54 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
2.2%
21/948 • 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.
|
5.5%
40/723 • Number of events 50 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
42/724 • Number of events 45 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
46/728 • 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.
|
|
Gastrointestinal disorders
Nausea
|
10.4%
99/948 • Number of events 135 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
28.9%
209/723 • Number of events 333 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
35.9%
260/724 • Number of events 447 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.7%
245/728 • Number of events 391 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
3.5%
33/948 • 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.
|
13.0%
94/723 • Number of events 139 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.4%
155/724 • Number of events 285 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
24.0%
175/728 • Number of events 344 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
1.6%
15/948 • 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.
|
3.6%
26/723 • 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.
|
3.5%
25/724 • Number of events 31 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
37/728 • 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.
|
|
Infections and infestations
Covid-19
|
5.3%
50/948 • 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.
|
6.1%
44/723 • 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.
|
7.2%
52/724 • Number of events 54 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
54/728 • 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.
|
|
Infections and infestations
Gastroenteritis
|
3.8%
36/948 • 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.
|
6.1%
44/723 • Number of events 52 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
41/724 • Number of events 50 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
50/728 • 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.
|
|
Infections and infestations
Influenza
|
7.7%
73/948 • Number of events 88 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.4%
68/723 • Number of events 84 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.0%
58/724 • Number of events 66 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
44/728 • Number of events 53 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
7.8%
74/948 • Number of events 106 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
55/723 • Number of events 79 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
61/724 • Number of events 82 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
47/728 • Number of events 65 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
10.9%
103/948 • Number of events 144 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.4%
75/723 • Number of events 100 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.4%
75/724 • 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.
|
8.8%
64/728 • Number of events 82 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
3.2%
30/948 • 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.
|
5.8%
42/723 • Number of events 49 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
61/724 • Number of events 72 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
53/728 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
60/948 • Number of events 69 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
34/723 • 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.
|
5.1%
37/724 • Number of events 43 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
35/728 • Number of events 42 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
5.7%
54/948 • Number of events 67 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
33/723 • Number of events 43 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
38/724 • Number of events 43 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
45/728 • Number of events 47 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
|
7.5%
71/948 • Number of events 84 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.6%
62/723 • Number of events 79 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.4%
75/724 • Number of events 116 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.8%
71/728 • Number of events 88 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Anxiety
|
6.8%
64/948 • Number of events 73 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
37/723 • 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.
|
4.0%
29/724 • Number of events 31 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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%
27/728 • Number of events 31 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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
Alopecia
|
2.4%
23/948 • 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.
|
4.1%
30/723 • 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.
|
5.0%
36/724 • 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.
|
5.4%
39/728 • Number of events 43 • Baseline Up to Week 74
* All randomized participants who received at least one dose of the study drug. Based on the planned safety analysis, adverse events were 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