Trial Outcomes & Findings for A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes (NCT NCT04560998)

NCT ID: NCT04560998

Last Updated: 2025-12-12

Results Overview

Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 792 participants
• Primary outcome timeframe: Baseline (week 0), end of treatment (week 52)
• Results posted on: 2025-12-12

Participant Flow

The trial was conducted at 129 sites in 21 countries.

Participants were randomized in a 1:1 ratio to receive treatment with either semaglutide or placebo as an adjunct to standard-of-care.

Participant milestones

Measure	Semaglutide Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Overall Study STARTED	396	396
Overall Study Full Analysis Set	396	396
Overall Study Safety Analysis Set	396	395
Overall Study COMPLETED	366	379
Overall Study NOT COMPLETED	30	17

Reasons for withdrawal

Measure	Semaglutide Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Overall Study Withdrawal by Subject	18	12
Overall Study Lost to Follow-up	8	5
Overall Study Physician Decision	4	0

Baseline Characteristics

A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

Baseline characteristics by cohort

Measure	Semaglutide n=396 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=396 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.	Total n=792 Participants Total of all reporting groups
Sex: Female, Male Female	107 Participants n=26 Participants	88 Participants n=24 Participants	195 Participants n=50 Participants
Age, Continuous	66.2 Years STANDARD_DEVIATION 9.71 • n=26 Participants	67.0 Years STANDARD_DEVIATION 8.96 • n=24 Participants	66.6 Years STANDARD_DEVIATION 9.35 • n=50 Participants
Sex: Female, Male Male	289 Participants n=26 Participants	308 Participants n=24 Participants	597 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=26 Participants	6 Participants n=24 Participants	13 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	388 Participants n=26 Participants	385 Participants n=24 Participants	773 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=26 Participants	5 Participants n=24 Participants	6 Participants n=50 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=26 Participants	1 Participants n=24 Participants	1 Participants n=50 Participants
Race/Ethnicity, Customized Asian	131 Participants n=26 Participants	109 Participants n=24 Participants	240 Participants n=50 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=26 Participants	0 Participants n=24 Participants	1 Participants n=50 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=26 Participants	4 Participants n=24 Participants	8 Participants n=50 Participants
Race/Ethnicity, Customized White	259 Participants n=26 Participants	279 Participants n=24 Participants	538 Participants n=50 Participants
Race/Ethnicity, Customized Other	1 Participants n=26 Participants	3 Participants n=24 Participants	4 Participants n=50 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

Outcome measures

Measure	Semaglutide n=338 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=345 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Maximum Walking Distance on a Constant Load Treadmill Test	1.21 Ratio of maximum walking distance Interval 0.95 to 1.55	1.08 Ratio of maximum walking distance Interval 0.86 to 1.36

SECONDARY outcome

Timeframe: Baseline (week 0), end of follow-up (week 57)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in maximum walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants continue on the treadmill after indicating onset of pain and should continue as long as possible until pain limits further activity. This distance is noted as the maximum walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, which-ever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

Outcome measures

Measure	Semaglutide n=329 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=333 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Follow-up Change in Maximum Walking Distance on a Constant Load Treadmill Test	1.16 Ratio of maximum walking distance Interval 0.92 to 1.48	1.10 Ratio of maximum walking distance Interval 0.87 to 1.4

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in VascuQoL-6 score is presented. VascuQoL-6 is a peripheral artery disease-specific questionnaire with 6 items covering social, emotional, functional as well as pain- and symptom-related aspects of the patient´s overall quality of life. Each item has a 4-point response scale (where 1 = worst score and 4 = best score). The endpoint analysed is the total score (range: 6-24) generated by summing the scores from all items. A higher score indicates better health status. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

Outcome measures

Measure	Semaglutide n=362 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=362 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Score	2.0 Scores on a scale Interval 0.0 to 4.0	1.0 Scores on a scale Interval -1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stopping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

Outcome measures

Measure	Semaglutide n=338 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=344 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Pain-free Walking Distance on a Constant Load Treadmill Test	1.21 Ratio of pain-free walking distance Interval 0.92 to 1.52	1.10 Ratio of pain-free walking distance Interval 0.86 to 1.44

SECONDARY outcome

Timeframe: Baseline (week 0), end of follow-up (week 57)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in pain-free walking distance on a constant load treadmill test is presented. The constant-load treadmill test with fixed speed (3.2 km/h, 2 mph) and fixed inclination (12%) is a standardised method for functional assessment of patients with peripheral artery disease. Participants are instructed to when pain starts in either leg and to continue on the treadmill without stop-ping at this stage. The distance walked is noted as the pain-free walking distance. The outcome measure was evaluated based on data from in-study observation period. In-study observation period is defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

Outcome measures

Measure	Semaglutide n=329 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=333 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Follow-up Change in Pain-free Walking Distance on a Constant Load Treadmill Test	1.18 Ratio of pain-free walking distance Interval 0.92 to 1.59	1.10 Ratio of pain-free walking distance Interval 0.83 to 1.48

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in HbA1c from baseline to week 52 in percentage-point is presented. The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=304 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=311 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Glycosylated Haemoglobin (HbA1c)	-0.8 Percentage-point of HbA1c Standard Deviation 1.1	0.2 Percentage-point of HbA1c Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in body weight from baseline to week 52 in kilogram (kg) is presented. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=310 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=318 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Body Weight	-5.2 Kilogram (kg) Standard Deviation 4.8	-1.2 Kilogram (kg) Standard Deviation 4.2

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in systolic blood pressure from baseline to week 52 is presented.The outcome measure is evaluated based on the on treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=310 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=319 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Systolic Blood Pressure	-4 Millimetre of mercury (mmHg) Standard Deviation 15	-1 Millimetre of mercury (mmHg) Standard Deviation 18

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in total cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=305 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=312 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Total Cholesterol	0.96 Ratio of total cholesterol Geometric Coefficient of Variation 20.18	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 19.88

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in LDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=294 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=296 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Low-density Lipoprotein (LDL)-Cholesterol	0.99 Ratio of LDL Geometric Coefficient of Variation 38.37	1.03 Ratio of LDL Geometric Coefficient of Variation 42.27

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in HDL-cholesterol from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=294 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=295 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in High Density Lipoprotein (HDL)-Cholesterol	1.04 Ratio of HDL Geometric Coefficient of Variation 15.95	0.99 Ratio of HDL Geometric Coefficient of Variation 13.91

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in Triglycerides from baseline to week 52 is presented as ratio to baseline. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=305 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=310 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Triglycerides	0.80 Ratio of triglycerides Geometric Coefficient of Variation 45.95	0.95 Ratio of triglycerides Geometric Coefficient of Variation 41.73

SECONDARY outcome

Timeframe: Screening (week -2), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in ABI from baseline to week 52 is presented. ABI is calculated as a ratio of the higher ankle systolic pressure to the higher systolic pressure measured in both arms. ABI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. An ABI between 1.0 to 1.4 is considered the normal range. An ABI between 0.90 to 0.99 is considered borderline. An ABI less than 0.90 indicates peripheral artery disease (PAD). The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=306 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=315 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Ankle-Brachial Index (ABI)	1.06 Ratio of ABI Geometric Coefficient of Variation 34.0	1.02 Ratio of ABI Geometric Coefficient of Variation 19.6

SECONDARY outcome

Timeframe: Screening (week -2), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in TBI from baseline to week 52 is presented. TBI is calculated as a ratio of the toe systolic pressure to the higher systolic pressure measured in both arms. TBI is measured at both left and right leg and the analysis endpoint is defined as the lower of the two indices. A TBI range of above or equal to 0.7 is considered normal, whereas a TBI less than 0.7 is considered abnormal. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=297 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=301 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Toe-Brachial Index (TBI)	1.07 Ratio of TBI Geometric Coefficient of Variation 34.4	1.04 Ratio of TBI Geometric Coefficient of Variation 37.3

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in WIQ global score from baseline to week 52 is presented. WIQ consists of three domains, speed, distance, and stair climbing, consisting of in total 14 questions. Each response is weighted based on the difficulty of the task. Domain scores are determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. Global score is calculated as the mean of the three domain scores (ranged from 0% to 100%). A global score of 0% represents inabil-ity to perform any of the tasks and 100% represents no difficulty with any of the tasks. Higher scores indicate better walking ability and less impairment. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=312 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=321 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Walking Impairment Questionnaire (WIQ) Global Score	9.48 %-point scores on a scale Standard Deviation 18.63	6.51 %-point scores on a scale Standard Deviation 20.53

SECONDARY outcome

Timeframe: Baseline (week 0), end of treatment (week 52)

Population: Full Analysis Set (FAS). Overall Number of Participants Analyzed = number of participants with available data for this outcome measure.

Change in SF-36 physical functioning domain from baseline to week 52 is presented. SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2 (acute version) questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores (Range: 19.03 to 57.60) to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A positive change score indicates an improvement in participant health stats. The outcome measure is evaluated based on the on-treatment without rescue treatment observation period. This period includes assessments and events for the time period where participants were exposed to trial product and before rescue treatment (medication or revascularisation procedure).

Outcome measures

Measure	Semaglutide n=311 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=320 Participants Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Change in Short Form 36 (SF-36) Physical Functioning Domain	2.98 Scores on a scale Standard Deviation 7.32	1.52 Scores on a scale Standard Deviation 7.17

Adverse Events

Semaglutide

Serious events: 74 serious events

Other events: 47 other events

Deaths: 4 deaths

Placebo

Serious events: 78 serious events

Other events: 24 other events

Deaths: 9 deaths

Serious adverse events

Measure	Semaglutide n=396 participants at risk Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=395 participants at risk Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Cardiac disorders Acute coronary syndrome	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Renal and urinary disorders Acute kidney injury	0.76% 3/396 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Acute myocardial infarction	0.76% 3/396 • Number of events 5 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	1.3% 5/395 • Number of events 5 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Metabolism and nutrition disorders Alkalosis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Blood and lymphatic system disorders Anaemia	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Anal abscess	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Angina pectoris	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Angina unstable	0.76% 3/396 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Ankle fracture	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Appendicitis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Arteriosclerosis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Respiratory, thoracic and mediastinal disorders Asthma	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Atrial fibrillation	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Atrial flutter	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Musculoskeletal and connective tissue disorders Back pain	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage 0, with cancer in situ	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Brain abscess	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Brain contusion	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations COVID-19	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations COVID-19 pneumonia	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Cardiac failure	0.51% 2/396 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Cardiac failure acute	0.51% 2/396 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Cardiac failure chronic	0.51% 2/396 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Cardio-respiratory arrest	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Cardiogenic shock	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Carotid artery restenosis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Carotid artery stenosis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Eye disorders Cataract	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Abdominal abscess	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Abdominal symptom	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Abscess limb	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Accelerated hypertension	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Cellulitis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Cerebral infarction	0.76% 3/396 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.76% 3/395 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Cerebrovascular accident	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Chronic gastritis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Clostridium difficile infection	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Concussion	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Constipation	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Coronary artery disease	1.0% 4/396 • Number of events 5 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Coronary artery occlusion	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Coronary artery stenosis	0.76% 3/396 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Cystitis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
General disorders Death	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Diabetic neuropathy	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Diverticulitis	0.76% 3/396 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Duodenitis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Erysipelas	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Facial paresis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Femur fracture	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Fracture displacement	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Gastric ulcer	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Gastritis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Congenital, familial and genetic disorders Hydrocele	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Metabolism and nutrition disorders Hyperkalaemia	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Hypertensive urgency	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders IIIrd nerve paralysis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Ileus paralytic	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Inguinal hernia	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Intermittent claudication	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Intestinal ischaemia	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Ischaemic cardiomyopathy	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Hepatobiliary disorders Ischaemic hepatitis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Ischaemic stroke	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Lacunar stroke	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Limb injury	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Liver abscess	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage II	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Myocardial ischaemia	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Renal and urinary disorders Nephrolithiasis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Investigations Neutrophil count decreased	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
General disorders Non-cardiac chest pain	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Metabolism and nutrition disorders Obesity	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Oesophagitis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Oesophagitis haemorrhagic	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Eye disorders Optic nerve disorder	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Orthostatic hypotension	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Pancreatic pseudocyst	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Musculoskeletal and connective tissue disorders Pathological fracture	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Pericardial effusion	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Pericarditis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Peripheral arterial occlusive disease	1.0% 4/396 • Number of events 4 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	1.3% 5/395 • Number of events 7 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Peripheral artery occlusion	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Peripheral artery stenosis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.51% 2/395 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Vascular disorders Peripheral ischaemia	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.76% 3/395 • Number of events 3 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Pneumonia	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	1.3% 5/395 • Number of events 5 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Pneumonia viral	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Polyneuropathy	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Post procedural haematuria	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Rectal abscess	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Renal and urinary disorders Renal failure	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Rib fracture	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Rotavirus infection	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Reproductive system and breast disorders Scrotal ulcer	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Sepsis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Septic endocarditis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Septic shock	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Cardiac disorders Sinus node dysfunction	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Skin and subcutaneous tissue disorders Skin ulcer	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Spinal fracture	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Stomach mass	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
General disorders Sudden cardiac death	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Syncope	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Injury, poisoning and procedural complications Tendon rupture	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
General disorders Tissue discolouration	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Nervous system disorders Transient ischaemic attack	0.51% 2/396 • Number of events 2 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Renal and urinary disorders Urinary retention	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Urinary tract infection	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Urosepsis	0.00% 0/396 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.25% 1/395 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Ear and labyrinth disorders Vertigo positional	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Infections and infestations Wound infection	0.25% 1/396 • Number of events 1 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.00% 0/395 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.

Other adverse events

Measure	Semaglutide n=396 participants at risk Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	Placebo n=395 participants at risk Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
Infections and infestations COVID-19	7.6% 30/396 • Number of events 32 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	5.3% 21/395 • Number of events 21 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.
Gastrointestinal disorders Nausea	5.6% 22/396 • Number of events 26 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.	0.76% 3/395 • Number of events 4 • Until week 57 All presented adverse events are treatment emergent adverse events (TEAEs). A Treatment Emergent Adverse Event (TEAE) is defined as an AE with onset in the on-treatment observation period.

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

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