Trial Outcomes & Findings for A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP) (NCT NCT05646706)
NCT ID: NCT05646706
Last Updated: 2026-04-23
Results Overview
Number of participants who achieve body weight reduction \>=5% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=5% and "no" defines participants who did not achieve body weight reduction \>=5%.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1407 participants
Primary outcome timeframe
At week 72
Results posted on
2026-04-23
Participant Flow
The trial was conducted at 90 sites in 11 countries as follows: Bulgaria, Canada, Germany, Greece, Hungary, Norway, Poland, Portugal, Slovakia, South Africa, and the Unites States.
The trial included a treatment period of 72 weeks (20 weeks of dose escalation and 52 weeks of maintenance period) followed by 9-week follow-up period. Participants were randomized in 5:1:1 ratio in either semaglutide 7.2 milligrams (mg), semaglutide 2.4 mg or placebo as an adjunct to reduced-calorie diet and increased physical activity.
Participant milestones
| Measure |
Semaglutide 7.2 mg
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 milligrams \[mg\], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Semaglutide 2.4 mg
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 milligrams \[mg\], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.
|
Placebo
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1005
|
201
|
201
|
|
Overall Study
Full Analysis Set
|
1005
|
201
|
201
|
|
Overall Study
Safety Analysis Set
|
1004
|
201
|
201
|
|
Overall Study
Magnetic Resonance Imaging (MRI) Analysis Set
|
43
|
6
|
6
|
|
Overall Study
COMPLETED
|
959
|
190
|
180
|
|
Overall Study
NOT COMPLETED
|
46
|
11
|
21
|
Reasons for withdrawal
| Measure |
Semaglutide 7.2 mg
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 milligrams \[mg\], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Semaglutide 2.4 mg
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 milligrams \[mg\], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.
|
Placebo
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
6
|
16
|
|
Overall Study
Lost to Follow-up
|
24
|
5
|
5
|
|
Overall Study
Physician Decision
|
4
|
0
|
0
|
Baseline Characteristics
A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
Baseline characteristics by cohort
| Measure |
Semaglutide 7.2 mg
n=1005 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Semaglutide 2.4 mg
n=201 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.
|
Placebo
n=201 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
Total
n=1407 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 Years
STANDARD_DEVIATION 12 • n=60 Participants
|
46 Years
STANDARD_DEVIATION 12 • n=56 Participants
|
48 Years
STANDARD_DEVIATION 12 • n=116 Participants
|
47 Years
STANDARD_DEVIATION 12 • n=7 Participants
|
|
Sex: Female, Male
Female
|
753 Participants
n=60 Participants
|
137 Participants
n=56 Participants
|
147 Participants
n=116 Participants
|
1037 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
252 Participants
n=60 Participants
|
64 Participants
n=56 Participants
|
54 Participants
n=116 Participants
|
370 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=60 Participants
|
12 Participants
n=56 Participants
|
7 Participants
n=116 Participants
|
63 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
961 Participants
n=60 Participants
|
189 Participants
n=56 Participants
|
194 Participants
n=116 Participants
|
1344 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
3 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
7 Participants
n=116 Participants
|
63 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=60 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=60 Participants
|
17 Participants
n=56 Participants
|
22 Participants
n=116 Participants
|
121 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
859 Participants
n=60 Participants
|
176 Participants
n=56 Participants
|
168 Participants
n=116 Participants
|
1203 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight
|
-19.5 Percentage (%) change in body weight
Standard Deviation 10.6
|
-3.8 Percentage (%) change in body weight
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of participants who achieve body weight reduction \>=5% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=5% and "no" defines participants who did not achieve body weight reduction \>=5%.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Yes
|
862 Participants
|
63 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
No
|
88 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of participants who achieve body weight reduction \>=10% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=10% and "no" defines participants who did not achieve body weight reduction \>=10%.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no)
Yes
|
783 Participants
|
35 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no)
No
|
167 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of participants who achieve body weight reduction \>=15% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=15% and "no" defines participants who did not achieve body weight reduction \>=15%.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no)
Yes
|
632 Participants
|
13 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no)
No
|
318 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of participants who achieve body weight reduction \>=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=20% and "no" defines participants who did not achieve body weight reduction \>=20%.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
Yes
|
453 Participants
|
5 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
No
|
497 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of participants who achieve body weight reduction \>=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=25% and "no" defines participants who did not achieve body weight reduction \>=25%.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
Yes
|
296 Participants
|
0 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
No
|
654 Participants
|
171 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference
|
-18.0 Centimeter (cm)
Standard Deviation 10.5
|
-5.6 Centimeter (cm)
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=189 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight
|
-19.5 Percentage (%) change in body weight
Standard Deviation 10.6
|
-16.4 Percentage (%) change in body weight
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.
Number of participants who achieve body weight reduction \>=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=20% and "no" defines participants who did not achieve body weight reduction \>=20%.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=189 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
Yes
|
453 Participants
|
63 Participants
|
|
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
No
|
497 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.
Number of participants who achieve body weight reduction \>=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction \>=25% and "no" defines participants who did not achieve body weight reduction \>=25%.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=189 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
Yes
|
296 Participants
|
29 Participants
|
|
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
No
|
654 Participants
|
160 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Body Weight
|
-21.7 Kilograms (kg)
Standard Deviation 12.3
|
-4.3 Kilograms (kg)
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI)
|
-7.7 kilogram per square meter (kg/m^2)
Standard Deviation 4.4
|
-1.5 kilogram per square meter (kg/m^2)
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.
Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=950 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=189 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight
|
-21.7 Kg
Standard Deviation 12.3
|
-18.7 Kg
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in Statistical Analysis Plan(SAP) section 4.3.2, the reporting groups semaglutide 7.2 and semaglutide 2.4 mg were planned to be pooled for analysis of the outcome measure. Hence, data is represented in singled pooled semaglutide (7.2mg + 2.4mg) arm.
Change in total fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=45 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=5 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%)
|
-26.9 % of total fat volume
Standard Deviation 18.1
|
-2.7 % of total fat volume
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
Change in total fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=45 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=5 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters)
|
-11.7 liters
Standard Deviation 8.8
|
-1.5 liters
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
Change in lean body volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=45 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=5 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%)
|
-7.5 % of lean body volume
Standard Deviation 7.4
|
-0.4 % of lean body volume
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
Change in lean body volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=45 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=5 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters)
|
-1.9 liters
Standard Deviation 2.0
|
-0.2 liters
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
Change in visceral fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=45 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=5 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%)
|
-33.6 % of visceral fat volume
Standard Deviation 22.9
|
-8.8 % of visceral fat volume
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
Change in visceral fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=45 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=5 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters)
|
-1.8 liters
Standard Deviation 1.3
|
-0.2 liters
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
Change in body weight (%) from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=46 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=5 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Pooled Semaglutide Versus Placebo: Change in Body Weight (%)
|
-18.4 % of body weight
Standard Deviation 11.9
|
-2.1 % of body weight
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.
Change in body weight (Kg) from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=46 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=5 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg)
|
-20.6 Kg
Standard Deviation 14.7
|
-2.7 Kg
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=949 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure
|
-10 millimeters of mercury (mmHg)
Standard Deviation 14
|
-4 millimeters of mercury (mmHg)
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=949 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=171 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure
|
-5 mmHg
Standard Deviation 9
|
-1 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=935 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=167 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline
|
0.94 Ratio of total cholesterol
Geometric Coefficient of Variation 16.7
|
1.00 Ratio of total cholesterol
Geometric Coefficient of Variation 16.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=935 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=167 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
|
0.94 Ratio of total cholesterol
Geometric Coefficient of Variation 16.7
|
1.00 Ratio of total cholesterol
Geometric Coefficient of Variation 16.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=921 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=165 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
|
1.08 Ratio of HDL cholesterol
Geometric Coefficient of Variation 15.9
|
1.02 Ratio of HDL cholesterol
Geometric Coefficient of Variation 15.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=921 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=165 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
|
1.08 Ratio of HDL cholesterol
Geometric Coefficient of Variation 15.9
|
1.02 Ratio of HDL cholesterol
Geometric Coefficient of Variation 15.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=921 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=165 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL)- Ratio to Baseline
|
0.92 Ratio of LDL cholesterol
Geometric Coefficient of Variation 25.5
|
0.98 Ratio of LDL cholesterol
Geometric Coefficient of Variation 28.6
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=921 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=165 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline
|
0.92 Ratio of LDL cholesterol
Geometric Coefficient of Variation 25.5
|
0.98 Ratio of LDL cholesterol
Geometric Coefficient of Variation 28.6
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=931 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=165 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline
|
0.76 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 39.3
|
1.00 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 36.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=931 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=165 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
|
0.76 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 39.3
|
1.00 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 36.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=933 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=165 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline
|
0.76 Ratio of triglycerides
Geometric Coefficient of Variation 40.9
|
0.99 Ratio of triglycerides
Geometric Coefficient of Variation 38.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=933 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=165 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline
|
0.76 Ratio of triglycerides
Geometric Coefficient of Variation 40.9
|
0.99 Ratio of triglycerides
Geometric Coefficient of Variation 38.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in hsCRP (milligram per liter \[mg/L\]) from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=934 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=167 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
|
0.38 Ratio of hsCRP
Geometric Coefficient of Variation 128.9
|
0.89 Ratio of hsCRP
Geometric Coefficient of Variation 89.9
|
SECONDARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of participants with change in lipid-lowering treatment from baseline (week 0) is presented in categories as decrease, no change and increase.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=163 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=28 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)
Decreased
|
8 Participants
|
0 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)
No change
|
138 Participants
|
22 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)
Increased
|
17 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At week 72Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of participants with change in antihypertensive treatment from baseline (week 0) is presented in categories as decrease, no change and increase.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=322 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=59 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)
Decreased
|
57 Participants
|
6 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)
No change
|
233 Participants
|
47 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)
Increased
|
32 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=938 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=167 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c)
|
-0.3 % of HbA1c
Standard Deviation 0.3
|
0.0 % of HbA1c
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=923 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=160 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose
|
-11.7 mg/dL
Standard Deviation 11.9
|
-1.7 mg/dL
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=902 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=158 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
|
0.61 Ratio of fasting serum insulin
Geometric Coefficient of Variation 66.6
|
0.90 Ratio of fasting serum insulin
Geometric Coefficient of Variation 62.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=902 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=158 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
|
0.61 Ratio of fasting serum insulin
Geometric Coefficient of Variation 66.6
|
0.90 Ratio of fasting serum insulin
Geometric Coefficient of Variation 62.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 72)Population: Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of participants with change in glycaemic category from baseline (week 0) to the end of treatment (week 72) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) \<5.7%; 2) Pre-diabetes: 5.7% \<= HbA1c \< 6.5%
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=951 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=168 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Normo-glycaemia (week 0) · Normo-glycaemia (week 72)
|
574 Participants
|
75 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Normo-glycaemia (week 0) · Pre-diabetes (week 72)
|
21 Participants
|
20 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Normo-glycaemia (week 0) · Diabetes (week 72)
|
0 Participants
|
2 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Pre-diabetes (week 0) · Normo-glycaemia (week 72)
|
297 Participants
|
26 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Pre-diabetes (week 0) · Pre-diabetes (week 72)
|
59 Participants
|
42 Participants
|
|
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Pre-diabetes (week 0) · Diabetes (week 72)
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 81)Population: Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=1004 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=201 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
|
6430 Events
|
743 Events
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 81)Population: Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=1004 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=201 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)
|
100 Events
|
16 Events
|
SECONDARY outcome
Timeframe: Baseline (week 0), End of treatment (week 72)Population: Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.
Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=872 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=140 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Placebo: Change in Pulse
|
1 Beats per minute (bpm)
Standard Deviation 10
|
-2 Beats per minute (bpm)
Standard Deviation 11
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 81)Population: Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.
Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=1004 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=201 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs
|
6430 Events
|
1133 Events
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 81)Population: Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.
Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
Outcome measures
| Measure |
Semaglutide 7.2 mg
n=1004 Participants
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Placebo
n=201 Participants
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|
|
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs
|
100 Events
|
31 Events
|
Adverse Events
Semaglutide 7.2 mg
Serious events: 73 serious events
Other events: 784 other events
Deaths: 0 deaths
Semaglutide 2.4 mg
Serious events: 22 serious events
Other events: 140 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 117 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Semaglutide 7.2 mg
n=1004 participants at risk
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Semaglutide 2.4 mg
n=201 participants at risk
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.
|
Placebo
n=201 participants at risk
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Immune system disorders
Anaphylactic reaction
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Atrial flutter
|
0.10%
1/1004 • Number of events 3 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Bell's palsy
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Hepatobiliary disorders
Biloma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast angiosarcoma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
2/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
General disorders
Capsular contracture associated with breast implant
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Cardiac failure
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Cardiac valve vegetation
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
General disorders
Chest pain
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.30%
3/1004 • Number of events 3 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.40%
4/1004 • Number of events 4 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.60%
6/1004 • Number of events 6 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
1.00%
2/201 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Complicated appendicitis
|
0.20%
2/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Psychiatric disorders
Depression
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Diverticulitis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
2/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Enteritis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Epilepsy
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Erysipelas
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Faecaloma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
2/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
General disorders
General physical health deterioration
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Heart failure with reduced ejection fraction
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Internal hernia
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Investigations
Liver function test increased
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Multiple sclerosis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
2/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Osteomyelitis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.20%
2/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Pneumonia
|
0.20%
2/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
2/1004 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Eye disorders
Retinal detachment
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 2 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Tension headache
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Undifferentiated connective tissue disease
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/1004 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Endocrine disorders
Goitre
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Psychiatric disorders
Psychotic disorder
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Sepsis
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.10%
1/1004 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
Other adverse events
| Measure |
Semaglutide 7.2 mg
n=1004 participants at risk
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.
|
Semaglutide 2.4 mg
n=201 participants at risk
Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72.
|
Placebo
n=201 participants at risk
Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
11.4%
114/1004 • Number of events 122 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
10.4%
21/201 • Number of events 22 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
11.9%
24/201 • Number of events 25 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
43/1004 • Number of events 50 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
7.0%
14/201 • Number of events 18 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
4.5%
9/201 • Number of events 11 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
51/1004 • Number of events 57 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
7.0%
14/201 • Number of events 15 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
2.0%
4/201 • Number of events 5 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Constipation
|
23.3%
234/1004 • Number of events 322 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
19.4%
39/201 • Number of events 62 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
9.0%
18/201 • Number of events 19 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
62/1004 • Number of events 92 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
6.0%
12/201 • Number of events 17 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
3.0%
6/201 • Number of events 6 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
58/1004 • Number of events 74 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
2.0%
4/201 • Number of events 5 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
5.0%
10/201 • Number of events 12 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.2%
72/1004 • Number of events 74 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
4.0%
8/201 • Number of events 8 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
1.5%
3/201 • Number of events 3 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.4%
74/1004 • Number of events 97 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
5.0%
10/201 • Number of events 17 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
4.5%
9/201 • Number of events 13 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
274/1004 • Number of events 507 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
27.9%
56/201 • Number of events 91 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
12.9%
26/201 • Number of events 39 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Dizziness
|
6.3%
63/1004 • Number of events 82 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
6.0%
12/201 • Number of events 14 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
1.5%
3/201 • Number of events 4 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
103/1004 • Number of events 140 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
6.0%
12/201 • Number of events 12 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
3.5%
7/201 • Number of events 8 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Eructation
|
9.2%
92/1004 • Number of events 130 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
8.0%
16/201 • Number of events 25 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
General disorders
Fatigue
|
11.2%
112/1004 • Number of events 153 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
9.5%
19/201 • Number of events 21 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
3.5%
7/201 • Number of events 10 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.8%
48/1004 • Number of events 55 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
6.5%
13/201 • Number of events 15 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
3.0%
6/201 • Number of events 33 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Headache
|
9.9%
99/1004 • Number of events 137 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
8.0%
16/201 • Number of events 26 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
8.5%
17/201 • Number of events 25 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Nervous system disorders
Hyperaesthesia
|
5.5%
55/1004 • Number of events 73 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.50%
1/201 • Number of events 1 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Vascular disorders
Hypertension
|
1.8%
18/1004 • Number of events 18 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
3.5%
7/201 • Number of events 7 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
6.0%
12/201 • Number of events 12 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
82/1004 • Number of events 117 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
7.5%
15/201 • Number of events 21 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
12.4%
25/201 • Number of events 34 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Nausea
|
43.7%
439/1004 • Number of events 907 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
38.3%
77/201 • Number of events 148 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
13.4%
27/201 • Number of events 40 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
7.1%
71/1004 • Number of events 101 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
0.00%
0/201 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Sinusitis
|
3.5%
35/1004 • Number of events 40 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
6.0%
12/201 • Number of events 15 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
4.0%
8/201 • Number of events 9 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
61/1004 • Number of events 74 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
6.5%
13/201 • Number of events 15 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
7.5%
15/201 • Number of events 17 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
|
Gastrointestinal disorders
Vomiting
|
24.8%
249/1004 • Number of events 524 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
16.4%
33/201 • Number of events 65 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
7.0%
14/201 • Number of events 23 • From baseline (week 0) to end of study (week 81)
Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER