Trial Outcomes & Findings for Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1) (NCT NCT05035095)
NCT ID: NCT05035095
Last Updated: 2026-05-07
Results Overview
Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
667 participants
Primary outcome timeframe
Baseline (week 0), end-of-treatment (week 68)
Results posted on
2026-05-07
Participant Flow
The trial was conducted at 50 sites in 9 countries as follows: Canada (5 sites), Denmark (3 sites), Finland (3 sites), France (5 sites), Germany (7 sites), Japan (3 sites), Poland (5 sites), Russia (8 sites) and United States (11 sites).
The trial included an initial 16-week dose-escalation period and a 52-week dose maintenance period. Participants were randomized in 1:1 ratio either to receive oral semaglutide 50 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.
Participant milestones
| Measure |
Oral Semaglutide 50 mg
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
Placebo
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
334
|
333
|
|
Overall Study
Full Analysis Set
|
334
|
333
|
|
Overall Study
Safety Analysis Set
|
334
|
333
|
|
Overall Study
COMPLETED
|
320
|
307
|
|
Overall Study
NOT COMPLETED
|
14
|
26
|
Reasons for withdrawal
| Measure |
Oral Semaglutide 50 mg
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
Placebo
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
14
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
Baseline characteristics by cohort
| Measure |
Oral Semaglutide 50 mg
n=334 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
Placebo
n=333 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Total
n=667 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 Years
STANDARD_DEVIATION 13 • n=54 Participants
|
50 Years
STANDARD_DEVIATION 12 • n=60 Participants
|
50 Years
STANDARD_DEVIATION 13 • n=114 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=54 Participants
|
238 Participants
n=60 Participants
|
485 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=54 Participants
|
95 Participants
n=60 Participants
|
182 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=54 Participants
|
13 Participants
n=60 Participants
|
27 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
288 Participants
n=54 Participants
|
296 Participants
n=60 Participants
|
584 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=54 Participants
|
24 Participants
n=60 Participants
|
56 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
246 Participants
n=54 Participants
|
248 Participants
n=60 Participants
|
494 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=54 Participants
|
22 Participants
n=60 Participants
|
43 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
36 Participants
n=54 Participants
|
36 Participants
n=60 Participants
|
72 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
28 Participants
n=54 Participants
|
23 Participants
n=60 Participants
|
51 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: Full analysis set (FAS) included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Percentage Change in Body Weight
|
-2.2 Percentage (%) change in body weight
Standard Deviation 7.2
|
-15.8 Percentage (%) change in body weight
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: At end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Number of participants who achieved weight loss greater than or equal to 5% of their baseline body weight (yes/no) at end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No)
Yes
|
76 Participants
|
269 Participants
|
|
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No)
No
|
219 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: At end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Number of participants who achieved weight loss greater than or equal ≥10% (Yes/No) at end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No)
Yes
|
35 Participants
|
220 Participants
|
|
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No)
No
|
260 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: At end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Number of participants who achieved weight loss greater than or equal (≥) 15% (Yes/No) at end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No)
Yes
|
17 Participants
|
170 Participants
|
|
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No)
No
|
278 Participants
|
147 Participants
|
SECONDARY outcome
Timeframe: At end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Number of participants who achieved weight loss greater than or equal (≥) 20% (Yes/No) at end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No)
Yes
|
8 Participants
|
107 Participants
|
|
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No)
No
|
287 Participants
|
210 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Waist Circumference
|
-2.8 centimeter (cm)
Standard Deviation 7.3
|
-13.4 centimeter (cm)
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-0.9 Kilogram per meter square (kg/m^2)
Standard Deviation 2.8
|
-5.9 Kilogram per meter square (kg/m^2)
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
Outcome measures
| Measure |
Placebo
n=278 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=298 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function
|
5.0 Score on a scale
Standard Deviation 19.9
|
14.5 Score on a scale
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in SF-36 v2.0 physical functioning domain from baseline (week 0) to end of treatment (week 68) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 (indicates population mean) with a SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning. A positive change score indicates an improvement since baseline.
Outcome measures
| Measure |
Placebo
n=280 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=303 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain
|
-0.0 Score on a scale
Standard Deviation 5.4
|
2.4 Score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-1 Millimeter of mercury (mmHg)
Standard Deviation 14
|
-7 Millimeter of mercury (mmHg)
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-1 Millimeter of mercury (mmHg)
Standard Deviation 10
|
-2 Millimeter of mercury (mmHg)
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=286 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=311 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
0.1 Percentage of HbA1c
Standard Deviation 0.3
|
-0.2 Percentage of HbA1c
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=292 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=313 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-1.8 Milligrams per deciliter (mg/dL)
Standard Deviation 10.4
|
-10.3 Milligrams per deciliter (mg/dL)
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in fasting serum insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to end-of-treatment (week 68) is presented as ratio to baseline.
Outcome measures
| Measure |
Placebo
n=260 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=275 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Fasting Serum Insulin (Pmol/L) - Ratio to Baseline
|
0.94 Ratio of fasting serum insulin
Geometric Coefficient of Variation 55.3
|
0.67 Ratio of fasting serum insulin
Geometric Coefficient of Variation 71.4
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in total cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=288 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=313 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Total Cholesterol (mg/dL) - Ratio to Baseline
|
1.01 Ratio of total cholesterol
Geometric Coefficient of Variation 16.6
|
0.97 Ratio of total cholesterol
Geometric Coefficient of Variation 17.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in high density lipoprotein (HDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=286 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=311 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
|
1.01 Ratio of HDL cholesterol
Geometric Coefficient of Variation 15.9
|
1.05 Ratio of HDL cholesterol
Geometric Coefficient of Variation 16.6
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in low density lipoprotein (LDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=286 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=311 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline
|
1.03 Ratio of LDL cholesterol
Geometric Coefficient of Variation 26.7
|
0.98 Ratio of LDL cholesterol
Geometric Coefficient of Variation 25.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in very low density lipoprotein (VLDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=288 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=312 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline
|
0.96 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 37.2
|
0.77 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 38.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in triglycerides (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=288 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=312 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Triglycerides (mg/dL) - Ratio to Baseline
|
0.96 Ratio of triglycerides
Geometric Coefficient of Variation 37.5
|
0.77 Ratio of triglycerides
Geometric Coefficient of Variation 38.4
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in free fatty acids (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=260 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=275 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
|
1.00 Ratio of free fatty acids
Geometric Coefficient of Variation 80.2
|
0.87 Ratio of free fatty acids
Geometric Coefficient of Variation 71.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in high sensitivity C-reactive protein (measured in Milligrams per liter (mg/L)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=288 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=314 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in High Sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline
|
0.85 Ratio of hsCRP
Geometric Coefficient of Variation 117.9
|
0.42 Ratio of hsCRP
Geometric Coefficient of Variation 129.9
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end-of-study (week 75)Population: SAS included All participants randomly assigned to study treatment and who took at least 1 dose of trial product. 'Overall Number of Participants Analysed' = participants with available data.
Number of treatment emergent adverse events from baseline (week 0) to end-of-study (week 75) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period. It is the time period in which participant was considered exposed to trial product.
Outcome measures
| Measure |
Placebo
n=333 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=334 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events
|
1577 Events
|
2500 Events
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end-of-study (week 75)Population: SAS included All participants randomly assigned to study treatment and who took at least 1 dose of trial product.
Number of serious adverse events from baseline (week 0) to end-of-study (week 75) is presented. A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or important medical event.
Outcome measures
| Measure |
Placebo
n=333 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=334 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Serious Adverse Events
|
48 Events
|
44 Events
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=295 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=317 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Body Weight - Kilogram (Kg)
|
-2.4 Kilogram (kg)
Standard Deviation 7.9
|
-16.1 Kilogram (kg)
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: At end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Number of participants who's body mass index (BMI) greater than or equal (≥) 30 at baseline and BMI lesser than (\<) 30 at week 68 (yes/no) from (week 0) to end-of-treatment (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=268 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=294 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Participants With Body Mass Index (BMI) Greater Than or Equal (≥) 30 at Baseline and BMI Lesser Than (<) 30 at Week 68 (Yes/no)
Yes
|
19 Participants
|
129 Participants
|
|
Number of Participants With Body Mass Index (BMI) Greater Than or Equal (≥) 30 at Baseline and BMI Lesser Than (<) 30 at Week 68 (Yes/no)
No
|
249 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: SAS included All participants randomly assigned to study treatment and who took at least 1 dose of trial product. 'Overall Number of Participants Analysed' = participants with available data.
Change in pulse from baseline (week 0) to end-of-study (week 68) is presented.
Outcome measures
| Measure |
Placebo
n=245 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=277 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Change in Pulse
|
-0 Beats/min
Standard Deviation 8
|
4 Beats/min
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Baseline (week 0), end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and end-of-treatment (week 68) are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) less than (\<) 5.7%; 2) Pre-diabetes: HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: HbA1c greater than or equal to (\>=) 6.5%.
Outcome measures
| Measure |
Placebo
n=333 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=334 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes)
Baseline (week 0) · normo-glycaemia
|
200 Participants
|
200 Participants
|
|
Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes)
Baseline (week 0) · pre-diabetes
|
130 Participants
|
132 Participants
|
|
Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes)
Baseline (week 0) · type 2 diabetes
|
3 Participants
|
2 Participants
|
|
Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes)
week 68 · normo-glycaemia
|
139 Participants
|
274 Participants
|
|
Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes)
week 68 · pre-diabetes
|
143 Participants
|
36 Participants
|
|
Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes)
week 68 · type 2 diabetes
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
The IWQOL-Lite-CT (measured as score on a scale) is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
Outcome measures
| Measure |
Placebo
n=278 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=298 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Participants With Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain (PFD) Greater Than or Equal (≥) 14.6 (Yes/No)
Yes
|
87 Participants
|
149 Participants
|
|
Number of Participants With Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain (PFD) Greater Than or Equal (≥) 14.6 (Yes/No)
No
|
191 Participants
|
149 Participants
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end-of-treatment (week 68)Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.
Number of participants with change in SF-36 v2.0 physical functioning score ≥ 3.7 (yes/no) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). A positive change score indicates an improvement since baseline. The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning.
Outcome measures
| Measure |
Placebo
n=280 Participants
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
Oral Semaglutide 50 mg
n=303 Participants
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
|---|---|---|
|
Number of Participants With Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Score Greater Than or Equal (≥) 3.7 (Yes/No)
Yes
|
56 Participants
|
113 Participants
|
|
Number of Participants With Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Score Greater Than or Equal (≥) 3.7 (Yes/No)
No
|
224 Participants
|
190 Participants
|
Adverse Events
Oral Semaglutide 50 mg
Serious events: 32 serious events
Other events: 292 other events
Deaths: 0 deaths
Placebo
Serious events: 29 serious events
Other events: 242 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Semaglutide 50 mg
n=334 participants at risk
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
Placebo
n=333 participants at risk
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Abscess limb
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.60%
2/333 • Number of events 2 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Investigations
Alanine aminotransferase increased
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Vascular disorders
Aortic dissection
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Appendicitis
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.60%
2/333 • Number of events 2 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
1/334 • Number of events 3 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
COVID-19
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.60%
2/334 • Number of events 2 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Renal and urinary disorders
Calculus urinary
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
General disorders
Chest pain
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
4/334 • Number of events 4 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Product Issues
Device dislocation
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 2 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Immune system disorders
Hypersensitivity
|
0.30%
1/334 • Number of events 2 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Surgical and medical procedures
Meniscus operation
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
1.2%
4/333 • Number of events 4 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Peritonitis
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Nervous system disorders
Seizure
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.30%
1/334 • Number of events 2 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.60%
2/333 • Number of events 2 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Eye disorders
Vision blurred
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/334 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.30%
1/333 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Vulval abscess
|
0.30%
1/334 • Number of events 1 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
0.00%
0/333 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
Other adverse events
| Measure |
Oral Semaglutide 50 mg
n=334 participants at risk
Participants received oral dose of semaglutide tablet once daily for 68 weeks. Participants initially received 3 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 50 mg was reached: 3 mg (week 1 to week 4); 7 mg (week 5 to week 8); 14 mg (week 9 to week 12); 25 mg (week 13 to week 16) and 50 mg (week 17 to week 68).
|
Placebo
n=333 participants at risk
Participants received oral dose of placebo matched to semaglutide tablet once daily for 68 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.5%
25/334 • Number of events 26 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
4.8%
16/333 • Number of events 19 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.6%
22/334 • Number of events 27 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
4.8%
16/333 • Number of events 19 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.3%
31/334 • Number of events 44 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
3.6%
12/333 • Number of events 16 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.9%
23/334 • Number of events 25 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
2.7%
9/333 • Number of events 9 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
22/334 • Number of events 26 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
11.4%
38/333 • Number of events 42 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
16/334 • Number of events 19 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
7.2%
24/333 • Number of events 37 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
COVID-19
|
35.6%
119/334 • Number of events 127 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
34.5%
115/333 • Number of events 121 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Constipation
|
27.5%
92/334 • Number of events 123 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
15.0%
50/333 • Number of events 71 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.8%
56/334 • Number of events 61 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
7.2%
24/333 • Number of events 26 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.6%
89/334 • Number of events 169 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
16.8%
56/333 • Number of events 70 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Nervous system disorders
Dizziness
|
8.1%
27/334 • Number of events 33 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
4.5%
15/333 • Number of events 18 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.1%
47/334 • Number of events 64 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
5.1%
17/333 • Number of events 19 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Eructation
|
9.6%
32/334 • Number of events 42 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
2.1%
7/333 • Number of events 7 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
General disorders
Fatigue
|
7.2%
24/334 • Number of events 28 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
6.0%
20/333 • Number of events 23 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
19/334 • Number of events 22 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
3.9%
13/333 • Number of events 15 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Gastroenteritis
|
5.4%
18/334 • Number of events 22 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
3.0%
10/333 • Number of events 10 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.7%
29/334 • Number of events 35 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
3.3%
11/333 • Number of events 12 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Nervous system disorders
Headache
|
13.8%
46/334 • Number of events 80 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
8.7%
29/333 • Number of events 36 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Vascular disorders
Hypertension
|
3.0%
10/334 • Number of events 12 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
6.6%
22/333 • Number of events 24 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Influenza
|
7.8%
26/334 • Number of events 37 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
5.4%
18/333 • Number of events 21 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
38/334 • Number of events 54 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
14.7%
49/333 • Number of events 73 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Nausea
|
51.8%
173/334 • Number of events 331 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
15.3%
51/333 • Number of events 64 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Sinusitis
|
3.6%
12/334 • Number of events 13 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
5.4%
18/333 • Number of events 24 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
19/334 • Number of events 26 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
6.0%
20/333 • Number of events 29 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
19/334 • Number of events 27 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
1.8%
6/333 • Number of events 6 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
80/334 • Number of events 154 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
3.6%
12/333 • Number of events 13 • From baseline (week 0) to end-of-study (week 75)
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Participants were analysed according to the treatment they actually received.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
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